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\u65e5\u672c\u6d77\u4e8b\u534f\u4f1a-\u578b\u5f0f\u8ba4\u53ef\u8bc1\u4e66 TA 19412E(R) 2019-4-19<\/td><\/tr>3<\/td> \u5357\u6d77\u897f\u90e8\u77f3\u6cb9\u6cb9\u7530\u670d\u52a1\uff08\u6df1\u5733\uff09\u6709\u9650\u516c\u53f8<\/td> \u6d77\u6d0b\u77f3\u6cb9\u6d6e\u5f0f\u751f\u4ea7\u50a8\u5378\u6cb9\u88c5\u7f6e\u56fd\u9645\u5e02\u573a\u51c6\u5165\u9879\u76ee<\/td> 2017.1-2018.12<\/td> \u5efa\u8bbe\u5185\u5bb9\uff1a\u672c\u9879\u76ee\u6d77\u6d0b\u77f3\u6cb9\u6d6e\u5f0f\u751f\u4ea7\u50a8\u5378\u6cb9\u88c5\u7f6e\u4e0a\u9762\u5305\u5bb9\u7740\u52a8\u529b\u6a21\u5757\u3001\u751f\u4ea7\u6a21\u5757\u3001\u50a8\u6cb9\u6a21\u5757\u3001\u6d88\u9632\u6a21\u5757\u3001\u751f\u6d3b\u6a21\u5757\u7b49\uff0c\u5728\u5e03\u5c40\u548c\u5206\u9694\u4e0a\u66f4\u52a0\u8bb2\u7a76\uff0c \u5b89\u5168\u6027\u95ee\u9898\u8981\u4f5c\u91cd\u70b9\u8003\u8651\u3002\u5728\u8bbe\u8ba1\u65f6\u9664\u4e86\u8fbe\u5230\u300a\u8239\u8236\u5efa\u9020\u5165\u7ea7\u89c4\u8303\u300b\u3001\u300a\u79fb\u52a8\u5f0f\u6d77\u4e0a\u5e73\u53f0\u5165\u7ea7\u5efa\u9020\u89c4\u8303\u300b\u3001\u300a\u6d6e\u5f0f\u751f\u4ea7\u7cfb\u7edf\u5165\u7ea7\u5efa\u9020\u89c4\u8303\u300b\u7b49\u901a\u7528\u6027\u89c4\u8303\u5916\uff0c\u8fd8\u6ee1\u8db3\u56fd\u9645\u6d77\u4e8b\u7ec4\u7ec7\uff08IMO\uff09\u7684MARPOL\u548cSOLAS \u516c\u7ea6\u7b49\u4e00\u4e9b\u884c\u4e1a\u6280\u672f\u6807\u51c6\uff08\u517138 \u79cd\u6807\u51c6\uff09\uff0c\u5b89\u5168\u3001\u6551\u751f\u3001\u73af\u4fdd\u7b49\u8981\u6c42\u9ad8\u3002\u672c\u9879\u76ee\u6d6e\u5f0f\u751f\u4ea7\u50a8\u5378\u6cb9\u88c5\u7f6e\u4e3a\u5355\u5e95\u53cc\u58f3\u8239\u5f62\u7ed3\u6784\uff0c\u8bbe\u8ba1\u4e3a\u6c38\u4e45\u4e0d\u89e3\u8131\u5f62\u5f0f\uff0c\u901a\u8fc7\u5185\u8f6c\u5854\u7531\u4f20\u7edf\u951a\u94fe\u52a0\u94a2\u4e1d\u7ef3\u7ec4\u6210\u7684\u5206\u6563\u951a\u6cca\u7cfb\u7edf\u5b9a\u4f4d\u3002
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\u5efa\u8bbe\u4f9d\u636e\uff1a\u516c\u53f8\u8fd1\u4e09\u5e74\u4e00\u5171\u83b7\u5f97\u4e8612\u9879\u77e5\u8bc6\u4ea7\u6743\uff0c\u5176\u4e2d\u53d1\u660e\u4e13\u52291\u9879\uff0c\u5b9e\u7528\u65b0\u578b\u4e13\u52293\u9879\u53ca\u8f6f\u4ef6\u8457\u4f5c\u6743\u4e13\u52298\u9879\u3002\u4e0e\u672c\u9879\u76ee\u76f8\u5173\u7684\u77e5\u8bc6\u4ea7\u6743\u5171\u8ba112\u9879\u3002\u56e0\u6b64\uff0c\u516c\u53f8\u5177\u5907\u5b9e\u65bd\u672c\u9879\u76ee\u7684\u6240\u6709\u57fa\u7840\u6761\u4ef6\u3002<\/td>123 <\/td> 61<\/td> \u4e2d\u56fd\u8239\u7ea7\u793e-\u6d77\u4e0a\u6d6e\u5f0f\u88c5\u7f6e\u5165\u7ea7\u8bc1\u4e66 GZ19U7000 2019-01-23
\u6cd5\u56fd\u8239\u7ea7\u793e\u5165\u7ea7\u8bc1\u4e66 02843S 2018-09-08<\/td><\/tr>\uff08\u4e8c\uff09\u3001\u9ad8\u7aef\u88c5\u5907\u5236\u9020\u4ea7\u4e1a-\u822a\u7a7a\u822a\u5929\u9886\u57df\uff086\u4e2a\u9879\u76ee\uff09<\/strong><\/td> \u3000<\/td> \u3000<\/td> \u3000<\/td> \u3000<\/td> \u3000<\/td> \u3000<\/td> \u3000<\/td> \u3000<\/td><\/tr> 1<\/td> \u6df1\u5733\u5e02\u4e2d\u8054\u5b87\u822a\u79d1\u6280\u6709\u9650\u516c\u53f8<\/td> \u8bed\u97f3\u76d1\u63a7\u6570\u636e\u91c7\u96c6\u7ec4\u4ef6PMA\u9002\u822a\u53d6\u8bc1<\/td> 2017.1-2018.7<\/td> \u5efa\u8bbe\u5185\u5bb9\uff1a\u8bbe\u8ba1\u548c\u5236\u9020\u8bed\u97f3\u76d1\u63a7\u6570\u636e\u91c7\u96c6\u7ec4\u4ef6\uff0c\u5e76\u901a\u8fc7\u4e2d\u56fd\u6c11\u7528\u822a\u7a7a\u7ba1\u5c40\u7684\u8bd5\u9a8c\u3001\u5ba1\u67e5\u3001\u6279\u51c6\uff0c\u83b7\u5f97PMA\u8bc1\u4e66\u3002
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\u96f6\u90e8\u4ef6\u5236\u9020\u4eba\u6279\u51c6\u4e66 PMA0065-18-ZN 2018-06-05
\u8865\u5145\u578b\u53f7\u5408\u683c\u8bc1 STC116-ZN 2018-03-27
\u8865\u5145\u578b\u53f7\u5408\u683c\u8bc1 10064698 REV.1 2018-09-04<\/td><\/tr>3<\/td> \u6df1\u5733\u5e02\u591a\u5c3c\u5361\u822a\u7a7a\u7535\u5b50\u6709\u9650\u516c\u53f8<\/td> \u6c11\u822aIFEC\u9002\u822a\u8ba4\u8bc1\u5e02\u573a\u51c6\u5165<\/td> 2018.1-2018.12<\/td> \u5efa\u8bbe\u5185\u5bb9\uff1a\u9879\u76ee\u53d6\u5f97CAAC\u9002\u822a\u8ba4\u8bc113\u9879\uff0c\u6d89\u53ca11\u4e2a\u4ea7\u54c1\uff0c\u5206\u522b\u4e3a\uff1a\u5ba2\u8231\u5a31\u4e50\u7cfb\u7edf\u89c6\u9891\u64ad\u653e\u5668\u6539\u88c5\u5305\u3001\u5ba2\u8231\u97f3\u9891\u64ad\u653e\u5668\u3001QACVR
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\u6c11\u7528\u822a\u7a7a\u5668\u6807\u51c6\u9002\u822a\u8bc1 AC8370 2018-04-28
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\u6c11\u7528\u822a\u7a7a\u5668\u6807\u51c6\u9002\u822a\u8bc1 AC10487 2018-12-15
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FDA U.S.F00D&DRUG K182648 2019-01-29
ETL 5010265 2019-05-30
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9726a-\u7684PMAC\u5d4c\u5165\u5f0f\u65e0\u7ebf\u6a21\u5757 U0186201.0800432 2018-12-12
\u53d8\u66f4\u901a\u77e5\u6279\u51c6\u91cd\u5927\u53d8\u66f4713154934 713154934 2019-03-25
DP-10\/DP-20\/DP-30\u5168\u6570\u5b57\u4fbf\u643a\u5f0f\u8d85\u58f0\u8bca\u65ad\u7cfb\u7edf 21CFR892.1550 2019-04-09
DC-90\/DC-90S\/DC-90Q\/DC-95\/DC-95S\/DC-88\/DC-88S\/DC-8 K190206 2019-03-08
ISO13485 QS60447510135Rev.00 2018-10-24
\u5173\u4e8e\u8bc1\u4e66G1180344751113\u7684\u786e\u8ba4 G1180344751113 2018-08-16
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\u56fd\u9645CE\u8ba4\u8bc1\u8bc1\u4e66 9925-2017-EC-RGC-NA-PS REV.1.0 2018-07-02
13485\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\u8bc1\u4e66 245939-2017-AQ-RGC-NA-PS Rev. 1.0 2019-02-07<\/td><\/tr>6<\/td> \u6df1\u5733\u5e02\u7279\u7ef4\u514b\u79d1\u6280\u6709\u9650\u516c\u53f8<\/td> \u751f\u7269\u533b\u836f\u4ea7\u4e1a\u5e02\u573a\u51c6\u5165\u8ba4\u8bc1\u9879\u76ee<\/td> 2017.1-2018.12<\/td> \u5efa\u8bbe\u5185\u5bb9\uff1a
1\u3001\u5e02\u573a\u8c03\u7814\uff0c\u5206\u6790\u5e02\u573a\u4e0a\u8840\u6c27\u63a2\u5934\u7684\u4f18\u7f3a\u70b9\uff0c\u548c\u6280\u672f\u65b9\u6848\uff0c\u627e\u51fa\u5229\u4e0e\u5f0a\uff0c\u5206\u6790\u6700\u4f18\u65b9\u6848\uff1b
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4 \u3001\u53cd\u590d\u6d4b\u8bd5\u5206\u6790\uff1b
5\u3001\u5e02\u573a\u63a8\u5e7f\u3002
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\u56fd\u9645CE\u8ba4\u8bc1\u8bc1\u4e66 CN19\/41002 2019.06.03
ISO13485\u8d28\u91cf\u4f53\u7cfb\u8ba4\u8bc1\u8bc1\u4e66 CN13\/31315 2019.01.31<\/td><\/tr>7<\/td> \u6df1\u5733\u5e02\u8d5b\u5c14\u751f\u7269\u6280\u672f\u6709\u9650\u516c\u53f8<\/td> \u533b\u7597\u5668\u68b0\u6ce8\u518c\u8bc1\u56fd\u5185\u5e02\u573a\u51c6\u5165\u9879\u76ee<\/td> 2017.7-2019.6<\/td> \u5efa\u8bbe\u5185\u5bb9\uff1a\u7533\u8bf7\u3001\u8ba4\u8bc1\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8bc1\u3002\u7814\u53d1\u3001\u751f\u4ea7\u4ee5\u73bb\u7483\u4e3a\u8f7d\u4f53\u7684\u86cb\u767d\u8d28\u82af\u7247\u68c0\u6d4b\u7cfb\u7edf\u3002
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\u672c\u6b21\u7533\u8bf7\u751f\u7269\u533b\u836f\u5e02\u573a\u51c6\u5165\u8bc1\u4e66:
1\u3001\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8bc1\uff08\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff09 \u7ca4\u68b0\u6ce8\u51c620182400244 \u8ba4\u8bc1\u65f6\u95f4:2018-02-08
2\u3001\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8bc1\uff08\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff09 \u7ca4\u68b0\u6ce8\u51c620182400245 \u8ba4\u8bc1\u65f6\u95f4:2018-02-08
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1\u3001\u5e02\u573a\u8c03\u7814\uff0c\u5206\u6790\u5e02\u573a\u4e0a\u8840\u6c27\u63a2\u5934\u7684\u4f18\u7f3a\u70b9\uff0c\u548c\u6280\u672f\u65b9\u6848\uff0c\u627e\u51fa\u5229\u4e0e\u5f0a\uff0c\u5206\u6790\u6700\u4f18\u65b9\u6848\u3002
2\u3001\u786e\u5b9a\u6700\u4f18\u65b9\u6848\u7684\u53ef\u884c\u6027\uff0c\u5206\u6790\u662f\u5426\u4f1a\u6709\u4fb5\u6743\u884c\u4e3a\u3002
3\u3001\u7740\u624b\u7814\u53d1\uff0c\u8d2d\u4e70\u8bbe\u5907\u6750\u6599\uff0c\u7533\u8bf7\u56fd\u9645\u8ba4\u8bc1\u3002
4\u3001\u53cd\u590d\u6d4b\u8bd5\u5206\u6790\u3002
5\u3001\u5e02\u573a\u63a8\u5e7f\u3002
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1) \u6838\u5fc3\u6280\u672f\uff1a
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2) \u521b\u65b0\u70b9\uff1a
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premarket notification K182839 2019-02-28<\/td><\/tr>12<\/td> \u6df1\u5733\u5e02\u6770\u7eb3\u745e\u533b\u7597\u4eea\u5668\u80a1\u4efd\u6709\u9650\u516c\u53f8<\/td> \u6218\u7565\u6027\u65b0\u5174\u4ea7\u4e1a\u53d1\u5c55\u8d44\u91d1\u65b0\u5174\u4ea7\u4e1a\u6276\u6301\u2014\u56fd\u9645CE\u8ba4\u8bc1\u5e02\u573a\u51c6\u5165\u6276\u6301\u9879\u76ee<\/td> 2018.1-2018.12<\/td> \u5efa\u8bbe\u5185\u5bb9\uff1a\u901a\u8fc7\u4f20\u611f\u5668\u611f\u5e94\u5404\u79cd\u751f\u7406\u53d8\u5316\uff0c\u7136\u540e\u653e\u5927\u5668\u628a\u4fe1\u606f\u5f3a\u5316\uff0c\u518d\u8f6c\u6362\u6210\u7535\u4fe1\u606f\uff0c\u7ecf\u8fc7\u6570\u636e\u5206\u6790\u8f6f\u4ef6\u5bf9\u6570\u636e\u8fdb\u884c\u8ba1\u7b97\uff0c\u5206\u6790\u548c\u7f16\u8f91\uff0c\u7136\u540e\u5728\u663e\u793a\u5c4f\u4e2d\u7684\u5404\u4e2a\u529f\u80fd\u6a21\u5757\u663e\u793a\u51fa\u6765\uff0c\u6216\u6839\u636e\u9700\u8981\u8bb0\u5f55\uff0c\u6253\u5370\u4e0b\u6765\uff0c\u5f53\u76d1\u6d4b\u7684\u6570\u636e\u8d85\u51fa\u8bbe\u5b9a\u7684\u6307\u6807\u65f6\uff0c\u5c31\u4f1a\u6fc0\u53d1\u8b66\u62a5\u7cfb\u7edf\uff0c\u53d1\u51fa\u4fe1\u53f7\u5f15\u8d77\u533b\u62a4\u4eba\u5458\u7684\u6ce8\u610f\u3002\u6211\u516c\u53f8\u7684\u76d1\u62a4\u4eea\u5df2\u7ecf\u83b7\u5f97\u6b27\u76dfCE\u8ba4\u8bc1\uff0c\u4ea7\u54c1\u9500\u5f80\u4e16\u754c\u5404\u5730\u3002\u5728\u4ea7\u54c1\u8425\u9500\u65b9\u9762\uff0c\u6211\u516c\u53f8\u8bbe\u6709\u5b8c\u5584\u7684\u552e\u524d\u552e\u4e2d\u552e\u540e\u670d\u52a1\u4f53\u7cfb\uff0c\u5728\u56fd\u5185\uff0c\u8bbe\u670926\u4e2a\u529e\u4e8b\u5904\uff0c\u5728\u56fd\u5916\uff0c\u6770\u7eb3\u745e\u5ba2\u6237\u904d\u5e03\u5404\u5927\u6d32\u4e0a\u767e\u4e2a\u56fd\u5bb6\uff0c\u54c1\u724c\u83b7\u5f97\u5e7f\u5927\u5ba2\u6237\u8ba4\u540c\u3002
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\u5efa\u8bbe\u4f9d\u636e\uff1a\u516c\u53f8\u7684\u9ad8\u5c42\u7ba1\u7406\u4eba\u5458\u548c\u4e3b\u8981\u7814\u53d1\u4eba\u5458\u5927\u591a\u5728\u516c\u53f8\u6ce8\u518c\u524d\u5c31\u957f\u671f\u4ece\u4e8b\u591a\u53c2\u6570\u75c5\u4eba\u76d1\u62a4\u4eea\u4ea7\u54c1\u7814\u53d1\u5de5\u4f5c\uff0c\u6709\u8d85\u8fc7\u5341\u4e94\u5e74\u540c\u4e1a\u7ecf\u9a8c\u3002\u4ed6\u4eec\u4e3b\u8981\u4ee5\u535a\u58eb\u3001\u7855\u58eb\u4e3a\u9aa8\u5e72\u56e2\u961f\uff0c\u62e5\u6709\u4e00\u6d41\u7684\u79d1\u6280\u5f00\u53d1\u80fd\u529b\u3002<\/td>85 <\/td> 42<\/td> CE\u8ba4\u8bc1 13161-2018-CERGCNA-PS 2018-09-13
CE\u8ba4\u8bc1 9965-2017-CERGCNA-PSRev.1.0 2018-10-17<\/td><\/tr>13<\/td> \u6df1\u5733\u6e90\u52a8\u521b\u65b0\u79d1\u6280\u6709\u9650\u516c\u53f8<\/td> \u751f\u7269\u533b\u836f\u4ea7\u4e1a\u5e02\u573a\u51c6\u5165\u8ba4\u8bc1\u9879\u76ee<\/td> 2017.1-2018.12<\/td> \u5efa\u8bbe\u5185\u5bb9\uff1a\u201cCE\u201d\u6807\u5fd7\u662f\u4e00\u79cd\u5b89\u5168\u8ba4\u8bc1\u6807\u5fd7\uff0c\u88ab\u89c6\u4e3a\u5236\u9020\u5546\u6253\u5f00\u5e76\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u62a4\u7167\u3002CE \u4ee3\u8868\u6b27\u6d32\u7edf\u4e00\uff08 CONFORMITE EUROPEENNE\uff09\u3002CE \u8ba4\u8bc1\uff0c\u4e3a\u5404\u56fd\u4ea7\u54c1\u5728\u6b27\u6d32\u5e02\u573a\u8fdb\u884c\u8d38\u6613\u63d0\u4f9b\u4e86\u7edf\u4e00\u7684\u6280\u672f\u89c4\u8303\uff0c\u7b80\u5316\u4e86\u8d38\u6613\u7a0b\u5e8f\u3002\u4efb\u4f55\u56fd\u5bb6\u7684\u4ea7\u54c1\u8981\u8fdb\u5165\u6b27\u76df\u3001\u6b27\u6d32\u81ea\u7531\u8d38\u6613\u533a\u5fc5\u987b\u8fdb\u884cCE \u8ba4\u8bc1\uff0c\u5728\u4ea7\u54c1\u4e0a\u52a0\u8d34 CE \u6807\u5fd7\u3002\u56e0\u6b64 CE \u8ba4\u8bc1\u662f\u4ea7\u54c1\u8fdb\u5165\u6b27\u76df\u53ca\u6b27\u6d32\u8d38\u6613\u81ea\u7531\u533a\u56fd\u5bb6\u5e02\u573a\u7684\u901a\u884c\u8bc1\u3002CE \u8ba4\u8bc1\u8868\u793a\u4ea7\u54c1\u5df2\u7ecf\u8fbe\u5230\u4e86\u6b27\u76df\u6307\u4ee4\u89c4\u5b9a\u7684\u5b89\u5168\u8981\u6c42;\u662f\u4f01\u4e1a\u5bf9\u6d88\u8d39\u8005\u7684\u4e00\u79cd\u627f\u8bfa\uff0c\u589e\u52a0\u4e86\u6d88\u8d39\u8005\u5bf9\u4ea7\u54c1\u7684\u4fe1\u4efb\u7a0b\u5ea6;\u8d34\u6709 CE \u6807\u5fd7\u7684\u4ea7\u54c1\u5c06\u964d\u4f4e\u5728\u6b27\u6d32\u5e02\u573a\u4e0a\u9500\u552e\u7684\u98ce\u9669\u3002\u901a\u8fc7\u8ba4\u8bc1\u9879\u76ee\u4e3b\u8981\u5185\u5bb9
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\u5efa\u8bbe\u76ee\u6807\uff1a\u9884\u8ba1\u52302020\u5e74\u5e74\u5e95\uff0c\u5c06\u7d2f\u8ba1\u8fbe\u6210\u9500\u552e\u989d3000\u4e07\u5143\u3001\u5229\u6da6500\u4e07\u5143\u3001\u7eb3\u7a0e80\u4e07\u5143\u3002<\/td>\u5355\u4f4d\u7b80\u4ecb\uff1a\u6df1\u5733\u6e90\u52a8\u521b\u65b0\u79d1\u6280\u6709\u9650\u516c\u53f8\u662f\u9ad8\u79d1\u6280\u521b\u65b0\u578b\u4f01\u4e1a\uff0c\u81f4\u529b\u4e8e\u4f18\u8d28\u9ad8\u6027\u4ef7\u6bd4\u5bb6\u7528\u533b\u7597\u7535\u5b50\u4ea7\u54c1\u7684\u7814\u53d1\u3001\u751f\u4ea7\u548c\u9500\u552e\uff0c\u4ee5\u591a\u53c2\u6570\u76d1\u62a4\u7cfb\u5217\u4ea7\u54c1\u4e3a\u4e3b\u3002\u516c\u53f8\u7684\u5b97\u65e8\u662f\u4ee5\u7528\u6237\u9700\u6c42\u548c\u6280\u672f\u521b\u65b0\u4e3a\u5f15\u5bfc\uff0c\u4e3a\u5927\u4f17\u63d0\u4f9b\u8d1f\u62c5\u5f97\u8d77\u7684\u9ad8\u54c1\u8d28\u533b\u7597\u4fdd\u5065\u4ea7\u54c1\u3002\u516c\u53f8\u5148\u540e\u83b7\u5f97\u6765\u81ea\u6df1\u5733\u5e02\u7684\u79d1\u6280\u8d44\u52a9\u4ee5\u53ca\u6765\u81ea\u4e8e\u533b\u7597\u5668\u68b0\u9f99\u5934\u4f01\u4e1a\u4e50\u666e\u533b\u7597\u7684\u6295\u8d44\uff0c\u516c\u53f8\u81ea\u6210\u7acb\u81f3\u4eca\uff0c\u81ea\u4e3b\u7814\u53d1\u4e86\u591a\u6b3e\u521b\u65b0\u4ea7\u54c1\uff0c\u5e76\u9646\u7eed\u83b7\u5f97\u6b27\u76dfCE\u8ba4\u8bc1\u3001\u65e5\u672c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8ba4\u8bc1\u3001\u7f8e\u56fdFDA\u8ba4\u8bc1\u4ee5\u53ca\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8ba4\u8bc1\uff0c\u4f53\u7cfb\u901a\u8fc7ISO 13485\u533b\u7597\u5668\u68b0\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\u4ee5\u53ca\u56fd\u5185GMP\u4f53\u7cfb\u5ba1\u6838\uff0c\u8fdc\u9500\u6570\u5341\u4e2a\u56fd\u5bb6\u3002\u516c\u53f8\u4e8e2016\u5e74\u83b7\u5f97\u56fd\u5bb6\u9ad8\u65b0\u6280\u672f\u4f01\u4e1a\u3002
\u5efa\u8bbe\u4f9d\u636e\uff1a\u76ee\u524d\u5df2\u7d2f\u8ba1\u7533\u8bf7\u83b7\u5f97\u5404\u9879\u77e5\u8bc6\u4ea7\u674344\u9879\u3002<\/td>80 <\/td> 40<\/td> \u6b27\u76dfCE\u8ba4\u8bc1\u8bc1\u4e66 HD 601239550001 2018-2-13
\u6b27\u76dfCE\u8ba4\u8bc1\u8bc1\u4e66 SX 601337060001 2018-12-18<\/td><\/tr>14<\/td> \u6df1\u5733\u8109\u52a8\u533b\u5b66\u6280\u672f\u6709\u9650\u516c\u53f8<\/td> \u8109\u52a8\u533b\u5b66\u56fd\u9645\u5e02\u573a\u51c6\u5165\u8ba4\u8bc1\u9879\u76ee<\/td> 2017.4-2019.3<\/td> \u5efa\u8bbe\u5185\u5bb9\uff1a\u672c\u9879\u76ee\u6295\u5165120.81\u4e07\u5143\uff0c\u7528\u4e8e\u4ea7\u54c1\u5e02\u573a\u51c6\u5165\u8ba4\u8bc1\u8d39\u7528\uff0c\u901a\u8fc7Mecross NC PTCA\u7403\u56ca\u5bfc\u7ba1\u7684EC\u8bbe\u8ba1-\u5ba1\u67e5\u8ba4\u8bc1\u3001\u4e00\u6b21\u6027PTCA\u7403\u56ca\u6269\u5f20\u5bfc\u7ba1\u7684\u8bbe\u8ba1\u751f\u4ea7EC\u5168\u9762\u8d28\u91cf\u4fdd\u8bc1\u4f53\u7cfb\u8ba4\u8bc1\u3001Mecross CTO PTCA\u7403\u56ca\u5bfc\u7ba1EC\u8bbe\u8ba1-\u5ba1\u67e5\u8ba4\u8bc1\uff0c\u4e3a\u672c\u516c\u53f8\u81ea\u4e3b\u7814\u53d1\u7684\u9ad8\u6027\u80fd\u7403\u56ca\u6269\u5f20\u5bfc\u7ba1\u7684\u4ea7\u4e1a\u5316\u63d0\u4f9b\u524d\u63d0\u6761\u4ef6\uff0c\u4fc3\u8fdb\u672c\u516c\u53f8\u81ea\u4e3b\u7814\u53d1\u6838\u5fc3\u6280\u672f\u7684\u79d1\u6280\u6210\u679c\u8f6c\u5316\u3002
\u5efa\u8bbe\u76ee\u6807\uff1a\u672c\u516c\u53f8\u5df2\u5b8c\u6210Mecross NC PTCA\u7403\u56ca\u5bfc\u7ba1\u7684EC\u8bbe\u8ba1-\u5ba1\u67e5\u8ba4\u8bc1\uff0c\u8bc1\u4e66\u7f16\u53f7\uff1aCE662150\uff1b\u4e00\u6b21\u6027PTCA\u7403\u56ca\u6269\u5f20\u5bfc\u7ba1\u7684\u8bbe\u8ba1\u751f\u4ea7EC\u5168\u9762\u8d28\u91cf\u4fdd\u8bc1\u4f53\u7cfb\u8ba4\u8bc1,\u8bc1\u4e66\u7f16\u53f7:CE 662147;Mecross CTO PTCA\u7403\u56ca\u5bfc\u7ba1EC\u8bbe\u8ba1-\u5ba1\u67e5\u8ba4\u8bc1\uff0c\u8bc1\u4e66\u7f16\u53f7\uff1aCE662147\u3002<\/td>\u5355\u4f4d\u7b80\u4ecb\uff1a\u6df1\u5733\u8109\u52a8\u533b\u5b66\u6280\u672f\u6709\u9650\u516c\u53f8\u6210\u7acb\u4e8e2014\u5e742\u670821\u65e5\uff0c\u6ce8\u518c\u8d44\u672c384.45\u4e07\u5143\uff0c\u662f\u4e00\u5bb6\u4e13\u6ce8\u4e8e\u5fc3\u8840\u7ba1\u548c\u5468\u8fb9\u8840\u7ba1\u75be\u75c5\u4ecb\u5165\u533b\u7597\u5668\u68b0\u7814\u53d1\u3001\u751f\u4ea7\u3001\u9500\u552e\u4e8e\u4e00\u4f53\u7684\u9ad8\u65b0\u6280\u672f\u4f01\u4e1a\u3002\u516c\u53f8\u6ce8\u91cd\u5bf9\u7814\u53d1\u7684\u6295\u5165\uff0c\u76ee\u524d\u6bcf\u5e74\u7814\u53d1\u6295\u5165\u5360\u9500\u552e\u989d\u768450%\u4ee5\u4e0a\uff0c\u5df2\u53d6\u5f97\u591a\u9879\u5177\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u524d\u6cbf\u6280\u672f\uff0c\u5e76\u79ef\u6781\u5f00\u5c55\u6838\u5fc3\u6280\u672f\u7684\u79d1\u6280\u6210\u679c\u8f6c\u5316\u548c\u4ea7\u54c1\u7684\u5e02\u573a\u51c6\u5165\u8d44\u683c\u7533\u8bf7\u5de5\u4f5c\u3002\u672c\u516c\u53f8\u4e8e2016\u5e7412\u6708\u83b7\u5f97\u6df1\u5733\u5e02\u9ad8\u65b0\u6280\u672f\u4f01\u4e1a\u8ba4\u5b9a\uff1b\u5e76\u4e8e2017\u5e748\u6708\uff0c\u901a\u8fc7\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb-ISO 13485\uff1a2003&EN ISO 13485\uff1a2012\u8ba4\u8bc1\uff1b\u8bc1\u4e66\u7f16\u53f7\uff1aMD 662153\uff1b2019\u5e743\u6708\u901a\u8fc7\u4e09\u9879CE\u8ba4\u8bc1\uff0c\u5206\u522b\u4e3aEC Design-Examination Certification\u8ba4\u8bc1\uff0c\u8bc1\u4e66\u7f16\u53f7\uff1aCE 662150\uff1b EC Certificate-Full Quality Assurance System\uff0c\u8bc1\u4e66\u7f16\u53f7\uff1aCE 662147\uff1bEC Design-Examination Certification\u8ba4\u8bc1\uff0c\u8bc1\u4e66\u7f16\u53f7\uff1aCE 662148\u3002
\u76ee\u524d\uff0c\u672c\u516c\u53f8\u62e5\u67091\u9879\u53d1\u660e\u4e13\u5229\uff0c1\u9879\u5b9e\u7528\u65b0\u578b\u4e13\u5229\uff0c1\u9879\u53d1\u660e\u4e13\u5229\u5904\u4e8e\u5b9e\u5ba1\u9636\u6bb5\u3002
\u5efa\u8bbe\u4f9d\u636e\uff1a\u672c\u9879\u76ee\u7684\u5efa\u8bbe\u57fa\u4e8e\u56fd\u52a1\u9662\u53d1\u5e03\u7684\u300a\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b\uff08\u56fd\u52a1\u9662\u4ee4\u7b2c650\u53f7\uff09\u300b\u3001\u300a\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff09\u300b\u3001\u300a\u6709\u6e90\u690d\u5165\u8d44\u6599\u5668\u68b0\u6307\u4ee4AIMDD\uff0890\/385\/EEC\uff09\u300b\u53caISO9001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3002<\/td>81 <\/td> 40<\/td> \u5168\u9762\u8d28\u91cf\u4fdd\u8bc1\u4f53\u7cfb\u8ba4\u8bc1 CE 662147 2019-03-15
EC \u8bbe\u8ba1-\u5ba1\u67e5\u8ba4\u8bc1 CE 662148 2019-03-15
EC \u8bbe\u8ba1-\u5ba1\u67e5\u8ba4\u8bc1 CE 662150 2019-03-15<\/td><\/tr>15<\/td> \u6df1\u5733\u5e02\u5b87\u8bfa\u751f\u7269\u6280\u672f\u6709\u9650\u516c\u53f8<\/td> \u5fc3\u808c\u6807\u8bc6\u7269\u53ca\u708e\u75c7\u68c0\u6d4b\u7c7b\u7279\u5b9a\u86cb\u767d\u8bd5\u5242\u4ea7\u4e1a\u5316<\/td> 2017.3-2019.3<\/td> \u5efa\u8bbe\u5185\u5bb9:\u672c\u9879\u76ee\u603b\u6295\u5165541.08\u4e07\u5143\uff0c\u5efa\u8bbe\u5730\u70b9\u4e3a\u6df1\u5733\u5e02\u9f99\u534e\u533a\u89c2\u6f9c\u8857\u9053\u65b0\u6f9c\u793e\u533a\u89c2\u5149\u8def1303\u53f7\u9e3f\u4fe1\u5de5\u4e1a\u56ed3\u53f7\u5382\u623f501\uff1b1\u53f7\u5382\u623f501\uff0c\u7cfb\u79df\u8d41\u7684\u73b0\u6709\u5382\u623f\uff0c\u5efa\u8bbe\u6d01\u51c0\u8f66\u95f4\u548c\u5b9e\u9a8c\u5ba4\uff0c\u8d2d\u7f6e\u81ea\u52a8\u5316\u751f\u4ea7\u8bbe\u5907\u548c\u7814\u53d1\u8bbe\u5907\uff0c\u5982\u5168\u81ea\u52a8\u5316\u5b66\u53d1\u5149\u514d\u75ab\u5206\u6790\u4eea\u3001\u514d\u75ab\u5206\u6790\u4eea\u7b49\u3002\u672c\u9879\u76ee\u81ea\u4e3b\u7814\u53d1\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff0c\u653b\u514b\u5355\u4eba\u4efd\u5316\u5b66\u53d1\u5149\u68c0\u6d4b\u6280\u672f\u548c\u8367\u5149\u514d\u75ab\u5c42\u6790\u68c0\u6d4b\u6280\u672f\uff0c\u5f00\u53d1\u51fa\u7528\u4e8e\u5b9a\u91cf\u68c0\u6d4b\u5fc3\u808c\u6897\u6b7b\u548c\u708e\u75c7\u7b49\u75be\u75c5\u7684\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\u3002
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TUV SUD Product Service Gmbh- CE\u8ba4\u8bc1 G20814940017Rev.00 2019-1-2
TUV SUD Product Service Gmbh- CE\u8ba4\u8bc1 G50814940015Rev.00 2019-1-2<\/td><\/tr>22<\/td> \u6df1\u5733\u5e02\u65b0\u9e3f\u9541\u533b\u7597\u5668\u68b0\u6709\u9650\u516c\u53f8<\/td> \u6df1\u5733\u5e02\u65b0\u9e3f\u9541\u533b\u7597\u5668\u68b0\u6709\u9650\u516c\u53f8\u6b27\u76dfCE\u8ba4\u8bc1\u548c\u7f8e\u56fdFDA\u8ba4\u8bc1\u9879\u76ee<\/td> 2017.1-2018.12<\/td> \u5efa\u8bbe\u5185\u5bb9\uff1a\u538b\u7f29\u5f0f\u96fe\u5316\u5668\u3001\u533b\u7528\u8d85\u58f0\u96fe\u5316\u5668\u3001\u533b\u7528\u5236\u6c27\u673a\u3001\u5438\u75f0\u5668\u7b49\u4ea7\u54c1\u7533\u8bf7\u6b27\u76dfCE\u8ba4\u8bc1\uff0c\u83b7\u5f97\u6b27\u76df\u533b\u7597\u5668\u68b0CE\u51c6\u5165\u8bc1\u4e66\u533b\u7528\u8d85\u58f0\u96fe\u5316\u5668\u7533\u8bf7\u7f8e\u56fdFDA\u8ba4\u8bc1\uff0c\u83b7\u5f97\u7f8e\u56fdFDA\u533b\u7597\u5668\u68b0\u51c6\u5165\u8bb8\u53ef\u3002
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\u7f8e\u56fdFDA\u8ba4\u8bc1 K170886 2018-06-21<\/td><\/tr>23<\/td> \u6df1\u5733\u5e02\u827e\u5229\u7279\u533b\u7597\u79d1\u6280\u6709\u9650\u516c\u53f8<\/td> \u6df1\u5733\u5e02\u827e\u5229\u7279\u533b\u7597\u79d1\u6280\u6709\u9650\u516c\u53f8\u56fd\u5185\u5e02\u573a\u51c6\u5165\u9879\u76ee<\/td> 2017.6-2019.5<\/td> \u5efa\u8bbe\u5185\u5bb9\uff1a\u75c9\u631b\u808c\u4f4e\u9891\u6cbb\u7597\u4eea\u3001\u4f4e\u9891\u8109\u51b2\u6cbb\u7597\u4eea\u3001\u5fc3\u80ba\u529f\u80fd\u6d4b\u8bd5\u7cfb\u7edf\u5c5e\u4e8e\u751f\u7269\u4fe1\u606f\u9ad8\u65b0\u6280\u672f\u9886\u57df\uff0c\u8be5\u4ea7\u54c1\u4e5f\u662f\u5065\u5eb7\u4ea7\u4e1a\u5eb7\u590d\u533b\u7597\u9886\u57df\u3002\u8be5\u9879\u76ee\u5728\u7814\u53d1\u8fc7\u7a0b\u4e2d\u6240\u6d89\u53ca\u5230\u7684\u521b\u65b0\u3001\u6280\u672f\u6210\u679c\uff1a\uff081\uff09\u77e5\u8bc6\u4ea7\u6743\uff1a\u8f6f\u4ef6\u8457\u4f5c\u6743\u3001\u5916\u89c2\u4e13\u5229\u3001\u5b9e\u7528\u65b0\u578b\u4e13\u5229\u7b49\u76f8\u5173\u77e5\u8bc6\u4ea7\u6743\uff1b\uff082\uff09\u4ea7\u54c1\u6ce8\u518c\uff1a\u4ea7\u54c1\u68c0\u9a8c\u62a5\u544a\u3001\u4ea7\u54c1\u7684\u6ce8\u518c\u6807\u51c6\u3001\u4ea7\u54c1\u7684CFDA\u6ce8\u518c\u8bc1\u4e66\u7b49\u76f8\u5173\u4ea7\u54c1\u8bc1\u4e66\uff1b\uff083\uff09\u4ea7\u54c1\u8ba4\u8bc1\uff1a\u4ea7\u54c1CFDA\u8ba4\u8bc1\u3001\u8f6f\u4ef6\u4ea7\u54c1\u767b\u8bb0\u7b49\u76f8\u5173\u8ba4\u8bc1\u3002
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2\u3001\u7ecf\u6d4e\u6307\u6807\uff1a\u9879\u76ee\u5efa\u8bbe\u5e26\u6765400\u4e07\u5143\u8425\u4e1a\u6536\u5165\u3002
3\u3001\u5e02\u573a\u6307\u6807\uff1a\u672c\u9879\u76ee\u7684\u80fd\u591f\u5f00\u62d3\u6b27\u76df\u56fd\u5185\u5916\u5e02\u573a\u3002
4\u3001\u5f62\u62105\u6761\u751f\u4ea7\u7ebf\u3002<\/td>\u5355\u4f4d\u7b80\u4ecb\uff1a\u672c\u516c\u53f8\u6210\u7acb\u4e8e2016\u5e7412\u670823\u65e5\uff0c\u6ce8\u518c\u8d44\u672c\u4e3a500\u4e07\u5143\uff0c\u4e3b\u8981\u4ea7\u54c1\u6709\u4e00\u6b21\u6027\u9ebb\u9189\u9762\u7f69\u4ea7\u54c1\u3002\u516c\u53f8\u6210\u7acb\u4ee5\u6765\uff0c\u4ea7\u54c1\u5728\u8d28\u91cf\u4e0a\u53d7\u5230\u5ba2\u6237\u7684\u559c\u7231\uff0c\u9010\u6e10\u9500\u5f80\u5168\u56fd\u5404\u5730\uff0c\u89c4\u6a21\u8d8a\u6765\u8d8a\u5927\uff0c\u5728\u884c\u4e1a\u4e0a\u5177\u6709\u826f\u597d\u7684\u5f71\u54cd\u529b\uff1b\u5176\u6b21\uff0c\u672c\u516c\u53f8\u7814\u53d1\u3001\u751f\u4ea7\u5e76\u9500\u552e\u4e00\u6b21\u6027\u9ebb\u9189\u9762\u7f69\uff0c\u5176\u539f\u6750\u6599\u662f\u9ad8\u5206\u5b50\u70ed\u5851\u6027\u6811\u8102\u6750\u6599\uff0c\u5177\u6709\u8282\u80fd\u73af\u4fdd\uff0c\u964d\u4f4e\u6c61\u67d3\uff0c\u91cd\u91cf\u8f7b\u7684\u7279\u6027\uff0c\u80fd\u591f\u4e3a\u793e\u4f1a\u5e26\u6765\u7eff\u8272\u73af\u4fdd\u7684\u6548\u76ca\uff1b\u672c\u516c\u53f8\u8bbe\u6709\u4e00\u652f\u4e13\u4e1a\u7684\u7814\u53d1\u56e2\u961f\uff0c\u4e13\u95e8\u7814\u53d1\u73af\u4fdd\u3001\u536b\u751f\u7684\u533b\u7597\u5668\u6750\uff0c\u5e76\u63d0\u9ad8\u4e86\u516c\u53f8\u7684\u7814\u53d1\u6210\u679c\u548c\u751f\u4ea7\u80fd\u529b\u3002
\u5efa\u8bbe\u4f9d\u636e\uff1a\u8be5\u9879\u76ee\u7684\u5efa\u8bbe\u7b26\u5408\u56fd\u5bb6\u3001\u7701\u3001\u5e02\u7684\u65b0\u5174\u4ea7\u4e1a\u653f\u7b56\u548c\u884c\u4e1a\u53d1\u5c55\u65b9\u5411\uff0c\u5df2\u7ecf\u5217\u5165\u5f53\u5730\u53d1\u5c55\u89c4\u5212\uff0c\u9879\u76ee\u5efa\u8bbe\u5355\u4f4d\u7b26\u5408\u56fd\u5bb6\u89c4\u5b9a\u7684\u4e2d\u5c0f\u4f01\u4e1a\u6807\u51c6\u3002<\/td>11 <\/td> 5<\/td> \u56fd\u9645CE\u8ba4\u8bc1\u8bc1\u4e66 GZ1733001 2018-8-20<\/td><\/tr> 26<\/td> \u6df1\u5733\u5f00\u7acb\u751f\u7269\u533b\u7597\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8<\/td> \u9ad8\u6e05\u7535\u5b50\u5185\u7aa5\u955c\u7cfb\u7edf\u5e02\u573a\u51c6\u5165\u9879\u76ee<\/td> 2017.6-2019.6<\/td> \u5efa\u8bbe\u5185\u5bb9\uff1a\u9879\u76ee\u5b9e\u65bd\u5185\u5bb9\u4e3b\u8981\u4e3a\u9ad8\u6e05\u5185\u7aa5\u955c\u4ea7\u4e1a\u5316\u3002\u4e3b\u8981\u5efa\u8bbe\u5185\u5bb9\u5305\u62ec\u9ad8\u6e05\u7535\u5b50\u5185\u7aa5\u955c\u7cfb\u7edf\u7814\u53d1\u53ca\u4ea7\u4e1a\u5316\u3002
\u5efa\u8bbe\u76ee\u6807\uff1a\u901a\u8fc7\u8d2d\u7f6e\u5149\u5b66\u6d4b\u8bd5\u5e73\u53f0\u7b49\u8bbe\u5907\u4eea\u5668\uff0c\u8fdb\u884c\u9ad8\u96c6\u6210\u9ad8\u6e05\u56fe\u50cf\u4f20\u611f\u5668\u82af\u7247\u8d85\u58f0\u5185\u7aa5\u955c\u3001\u7279\u6b8a\u5149\u8c31\u5149\u6e90\u3001\u5fae\u5c0f\u6210\u50cf\u6a21\u7ec4\u5c01\u88c5\u7b49\u6838\u5fc3\u90e8\u4ef6\u7814\u53d1\uff0c\u5efa\u8bbe\u5149\u5b66\u50cf\u8d28\u6d4b\u8bd5\u5ba4\u3001\u673a\u68b0\u5bff\u547d\u53ca\u53ef\u9760\u6027\u5b9e\u9a8c\u5ba4\u7b49\u5e73\u53f0\u3002\u5b9e\u73b0\u652f\u6301\u7279\u6b8a\u5149\u6210\u50cf\u3001\u5185\u7aa5\u955c\u8d85\u58f0\u8bca\u65ad\u7b49\u529f\u80fd\u7684\u9ad8\u6e05\u7535\u5b50\u5185\u7aa5\u955c\u7cfb\u7edf\u5e76\u83b7\u53d6\u76f8\u5173\u4e13\u5229\u3002<\/td>\u5355\u4f4d\u7b80\u4ecb\uff1a\u7597\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8\uff08\u4ee5\u4e0b\u7b80\u79f0\u5f00\u7acb\u533b\u7597\uff09\uff0c\u6210\u7acb\u4e8e2002\u5e749\u6708\uff0c\u662f\u4e13\u4e1a\u4ece\u4e8b\u533b\u7528\u5f69\u8272\u8d85\u58f0\u6210\u50cf\u7cfb\u7edf\uff08\u5f69\u8d85\uff09\u3001\u533b\u7528\u9ad8\u6e05\u7535\u5b50\u5185\u7aa5\u955c\u7684\u56fd\u5bb6\u7ea7\u9ad8\u65b0\u6280\u672f\u4f01\u4e1a\uff0c\u5176\u4e2d\u533b\u7528\u8d85\u58f0\u6210\u50cf\u8bbe\u5907\u5df2\u6392\u540d\u5168\u7403\u884c\u4e1a\u524d10\u540d\uff0c\u9ad8\u6e05\u5185\u7aa5\u955c\u5728\u56fd\u5185\u4f01\u4e1a\u4e2d\u4e5f\u5904\u4e8e\u9886\u5148\u5730\u4f4d\u3002
\u5f00\u7acb\u533b\u7597\u73b0\u62e5\u6709\u5458\u5de51700\u591a\u4eba\uff0c\u5176\u4e2d550\u540d\u4e13\u4e1a\u7814\u53d1\u4eba\u5458\uff0c\u5176\u4e2d\u535a\u58eb16\u4eba\uff0c\u7855\u58eb150\u591a\u4eba\uff0c\u53d6\u5f97\u9ad8\u7ea7\u804c\u79f0\u4eba\u545810\u4f59\u4eba\uff0c\u6bcf\u5e74\u7814\u53d1\u6295\u5165\u9ad8\u8fbe15~20%\u3002\u516c\u53f8\u5728\u7f8e\u56fd\u7845\u8c37\u3001\u897f\u96c5\u56fe\u3001\u65e5\u672c\u4e1c\u4eac\u8bbe\u7acb\u7814\u53d1\u4e2d\u5fc3\uff0c\u7acb\u8db3\u81ea\u4e3b\u521b\u65b0\u7814\u53d1\uff0c\u516c\u53f8\u5171\u83b7\u5f97\u4e13\u5229\u6388\u6743295\u9879\uff0c\u627f\u62c5\u8fc7\u79d1\u6280\u90e8\u56fd\u5bb6\u79d1\u6280\u652f\u6491\u8ba1\u5212\u3001\u79d1\u6280\u90e8\u56fd\u9645\u79d1\u6280\u5408\u4f5c\u9879\u76ee\u3001\u56fd\u5bb6\u53d1\u6539\u59d4\u9ad8\u6027\u80fd\u4e13\u9879\u3001\u5e7f\u4e1c\u7701\u79d1\u6280\u8ba1\u5212\u3001\u6df1\u5733\u5e02\u6280\u672f\u653b\u5173\u9879\u76ee\u7b49\u91cd\u5927\u9879\u76ee\u548c\u8bfe\u9898\uff0c\u516c\u53f8\u83b7\u51c6\u7ec4\u5efa\u4e86\u5e7f\u4e1c\u7701\u533b\u7528\u5f69\u8272\u8d85\u58f0\u6210\u50cf\u7cfb\u7edf\u5de5\u7a0b\u6280\u672f\u7814\u7a76\u4e2d\u5fc3\u3001\u6df1\u5733\u533b\u5b66\u8d85\u58f0\u6210\u50cf\u53ca\u6362\u80fd\u5668\u5de5\u7a0b\u6280\u672f\u7814\u7a76\u5f00\u53d1\u4e2d\u5fc3\u3001\u6df1\u5733\u5e02\u4f01\u4e1a\u6280\u672f\u4e2d\u5fc3\uff0c\u6df1\u5733\u5e02\u535a\u58eb\u540e\u521b\u65b0\u57fa\u5730\u7b49\u3002\u5f00\u7acb\u533b\u7597\u8d28\u91cf\u4f53\u7cfbISO9001\u3001ISO13485\u83b7\u6b27\u76dfDNV\u3001\u4e2d\u56fdCMD\u8ba4\u8bc1\uff1b\u4ea7\u54c1\u83b7\u7f8e\u56fdFDA\u3001\u6b27\u76dfCE\u548c\u4e2d\u56fdCFDA\u8ba4\u8bc1\u3002\u5f69\u8d85\u4ea7\u54c1\u73b0\u5df2\u6279\u91cf\u8fdb\u5165\u6b27\u76df\u3001\u5317\u7f8e\u7b49120\u591a\u4e2a\u56fd\u5bb6\u548c\u5730\u533a\u3002
2018\u5e74\u516c\u53f8\u9500\u552e\u6536\u516512\u4ebf\u5143.
\u5efa\u8bbe\u4f9d\u636e\uff1a\u5f00\u7acb\u5728\u5185\u955c\u7814\u53d1\u65b9\u9762\u79ef\u7d2f\u4e86\u4e30\u5bcc\u7ecf\u9a8c\uff0c\u5efa\u7acb\u8d77\u4e86\u4e00\u652f\u9ad8\u6c34\u5e73\u7684\u7814\u53d1\u56e2\u961f\u3002\u76ee\u524d\u5185\u7aa5\u955c\u7814\u53d1\u56e2\u961f70\u4f59\u4eba\uff0c\u5177\u6709\u6280\u672f\u9886\u57df\u8986\u76d6\u5149\u3001\u673a\u3001\u7535\uff0c\u7b97\u6cd5\uff0c\u6cd5\u89c4\uff0c\u4e34\u5e8a\u7b49\uff0c\u62e5\u6709\u5149\u5b66\u8d28\u91cf\u6d4b\u8bd5\u7cfb\u7edf\u3001\u5206\u5149\u5149\u5ea6\u8ba1\u7b49\u591a\u5957\u5149\u5b66\u53ca\u7535\u5b50\u7814\u53d1\u6d4b\u8bd5\u8bbe\u5907\u3002\u516c\u53f8\u5728\u8f6f\u6027\u5185\u7aa5\u955c\u955c\u4f53\u7684\u6280\u672f\u53d1\u5c55\uff0c\u5e02\u573a\u9700\u6c42\uff0c\u4f9b\u8d27\u6e20\u9053\uff0c\u52a0\u5de5\u6a21\u5f0f\u7b49\u6709\u6e05\u6670\u51c6\u786e\u7684\u628a\u63e1\uff0c\u5df2\u6210\u529f\u7814\u53d1\u9ad8\u6e05\u5185\u7aa5\u955c\u5e76\u901a\u8fc7\u6ce8\u518c\u68c0\u9a8c\u3002<\/td>204 <\/td> 102<\/td> \u5df4\u897f\u6ce8\u518c 81464750023 2019-05-27
FDA K173921 2018-09-05
NMPA \u7ca4\u68b0\u6ce8\u51c620182061081 2018-12-19
NMPA \u7ca4\u68b0\u6ce8\u51c620182061082 2018-12-19
NMPA \u7ca4\u68b0\u6ce8\u51c620192060025 2019-01-29
NMPA \u7ca4\u68b0\u6ce8\u51c620192060068 2019-01-30
NMPA \u7ca4\u68b0\u6ce8\u51c620162221252 2019-06-05
NMPA \u7ca4\u68b0\u6ce8\u51c620163221850 2019-06-03
NMPA \u7ca4\u68b0\u6ce8\u51c620163221851 2019-06-10
NMPA \u7ca4\u68b0\u6ce8\u51c620193061536 2019-01-29
NMPA \u7ca4\u68b0\u6ce8\u51c620193061533 2019-01-29
NMPA \u7ca4\u68b0\u6ce8\u51c620182220147 2018-01-29
NMPA \u7ca4\u68b0\u6ce8\u51c620182220148 2018-01-29
NMPA \u7ca4\u68b0\u6ce8\u51c620193060045 2019-01-17
NMPA \u7ca4\u68b0\u6ce8\u51c620193060043 2019-01-17
NMPA \u7ca4\u68b0\u6ce8\u51c620193060037 2019-01-17
NMPA \u7ca4\u68b0\u6ce8\u51c620193060046 2019-01-17
CE HD601280460001 2018-06-19<\/td><\/tr>27<\/td> \u6df1\u5733\u5e02\u4e1a\u805a\u5b9e\u4e1a\u6709\u9650\u516c\u53f8<\/td> Y\u578b\u8fde\u63a5\u5668\u5957\u4ef6\u548c\u4e00\u6b21\u6027\u4f7f\u7528\u5bfc\u5f15\u5bfc\u4e1d\u56fd\u5185\u5e02\u573a\u51c6\u5165\u9879\u76ee<\/td> 2017.6-2019.5<\/td> \u5efa\u8bbe\u5185\u5bb9\uff1a\u672c\u9879\u76ee\u4e3b\u8981\u662f\u6d89\u53ca\u6ce8\u5851\u6280\u672f\u3001\u706d\u83cc\u6280\u672f\u3001\u5236\u56fe\u6280\u672f\u548c\u751f\u7269\u76f8\u5bb9\u6027\u6280\u672f\u7b49\u76f8\u5173\u6280\u672f\u9886\u57df\uff0c\u4ee5\u53ca\u6750\u6599\u7684\u9009\u62e9\uff0c\u533b\u7597\u5668\u68b0\u76f8\u5173\u7684\u6cd5\u5f8b\u6cd5\u89c4\uff0c\u6d82\u5e03\u6d82\u5c42\u548c\u56fa\u5316\u7b49\u76f8\u5173\u5de5\u827a\u8303\u7574\u3002\u4e00\u6b21\u6027\u4f7f\u7528\u5bfc\u5f15\u5bfc\u4e1d\u4e3b\u8981\u91c7\u7528\u53d8\u5f84\u954d\u949b\u5408\u91d1\u4e1d\u548c\u805a\u5408\u7269\u5171\u6324\u5de5\u827a\u89e3\u51b3\u4e86\u5bfc\u5f15\u5bfc\u4e1d\u7684\u67d4\u987a\u6027\u3001\u63a8\u9001\u6027\u548c\u626d\u63a7\u6027\uff1b\u91c7\u7528\u4eb2\u6c34\u6d82\u5e03\u548c\u56fa\u5316\u5de5\u827a\u89e3\u51b3\u8868\u9762\u4eb2\u6c34\u6d82\u5c42\u7684\u9644\u7740\u529b\u7684\u63d0\u5347\u95ee\u9898\uff0c\u964d\u4f4e\u4e86\u5bfc\u5f15\u5bfc\u4e1d\u5916\u8868\u9762\u7684\u6469\u64e6\u529b\uff0c\u63d0\u5347\u5bfc\u4e1d\u5728\u8840\u7ba1\u5185\u7684\u901a\u8fc7\u6027\u3002\u901a\u8fc7\u5bf9Y\u578b\u8fde\u63a5\u5668\u7ed3\u6784\u53ca\u751f\u4ea7\u5de5\u827a\u8fdb\u884c\u4f18\u5316\u8bbe\u8ba1\uff0c\u5236\u5907\u4e00\u79cd\u5177\u6709\u7b26\u5408\u6807\u51c6\u7684Y\u578b\u8fde\u63a5\u5668\u3002\u89e3\u51b3\u4e86Y\u578b\u8fde\u63a5\u5668\u7684\u751f\u4ea7\u5de5\u827a\u95ee\u9898\uff0c\u4ee5\u53ca\u6750\u6599\u7684\u9009\u62e9\u95ee\u9898\uff0c\u4f7f\u5f97\u5728\u624b\u672f\u8fc7\u7a0b\u4e2d\u901a\u8fc7Y\u578b\u8fde\u63a5\u5668\u7684\u6b62\u8840\u9600\u8d77\u5230\u5f88\u597d\u7684\u6b62\u8840\u6548\u679c\uff0c\u4e14\u4e0e\u4eba\u4f53\u4e0d\u53d1\u751f\u6392\u65a5\u95ee\u9898\uff0c\u5177\u6709\u751f\u7269\u76f8\u5bb9\u6027\u3002
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