General Administration released the first medical device quality bulletin

Pharmaceutical Network January 24 hearing to strengthen the quality supervision and management of medical devices to ensure the safe and effective use of medical device products, the State Food and Drug Administration organized a bone screw, high potential treatment equipment, radiofrequency ablation equipment involving 43 companies 3 The products of 60 batches (sets) of varieties were subject to quality supervision and sampling, and the sampling items all met the standards and the specific sampling results are shown in the appendix.

Special announcement.

Serial number	Mark the product name	Was spot checks	Marking manufacturers	Specification	Production date / lot number / Serial number	Sampling unit	inspection entity
1	Metallic bone screws - Deep-screw cancellous bone screws (all teeth)	Henan Takao Industrial Co., Ltd.	Henan Takao Industrial Co., Ltd.	HBQ03 ∮ 4.0 * 48mm	150924-041	Henan Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute
2	Lock the bone screw	Beijing Fuller Technology Development Co., Ltd.	Beijing Fuller Technology Development Co., Ltd.	FSDT24 Φ5.0X50	150924-041	Beijing Food and Drug Administration	Zhejiang Medical Devices Testing Institute
3	Fracture screw	Beijing Baiyou Huatai Medical Technology Co., Ltd.	aap Implantate AG	SP 6516-55-2	I017	Beijing Food and Drug Administration	Zhejiang Medical Devices Testing Institute
4	Metal screw-HB type bone screw	Hohhot Austrian Year of Science and Technology Co., Ltd.	Changzhou Osmanthus Medical Devices Co., Ltd.	HBQ03 4.0 × 46 spherical (standard) full tooth	120981294	Inner Mongolia Autonomous Region Food and Drug Administration	Zhejiang Medical Devices Testing Institute
5	Metal bone screw	Wendeng City, Shandong Province Osteopathic Technology Development Co., Ltd.	Wendeng City, Shandong Province Osteopathic Technology Development Co., Ltd.	HAQ03 Ф4.0 × 25	1701006	Shandong Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute
6	Double-locking orbital arch compression metal plate fixation system components	Shenyang East Asia Medical Institute Co., Ltd.	Shenyang East Asia Medical Institute Co., Ltd.	HB6.5 * 50	1608	Liaoning Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute
7	Double-locking orbital arch compression metal plate fixation system components	Shenyang East Asia Medical Institute Co., Ltd.	Shenyang East Asia Medical Institute Co., Ltd.	HB6.5 * 55	1608	Liaoning Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute
8	Titanium bone screws	Chifeng Run Hong Medical Devices Co., Ltd.	Beijing Fuller Technology Development Co., Ltd.	HAQ02 Ф3.5 × 60	16011	Inner Mongolia Autonomous Region Food and Drug Administration	Zhejiang Medical Devices Testing Institute
9	Lock the metal bone screw	Chengde County Hospital	Suzhou Sunan Jiemai Medical Devices Co., Ltd.	HCJQBO34.0 * 28	L1703398T	Hebei Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute
10	Fracture screw	Beijing Baiyou Huatai Medical Technology Co., Ltd.	aap Implantate AG	SP 6500-30-2	I030	Beijing Food and Drug Administration	Zhejiang Medical Devices Testing Institute
11	Titanium bone screws	Beijing Fuller Technology Development Co., Ltd.	Beijing Fuller Technology Development Co., Ltd.	HBQ02 Φ4.0X40-14	15032	Beijing Food and Drug Administration	Zhejiang Medical Devices Testing Institute
12	Metal bone screw	Qinghai Yun Medical Devices Co., Ltd.	Changzhou Wujin Jinxing Medical Devices Co., Ltd.	HA2.0 * 20mm	1403004	Qinghai Provincial Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
13	Lock metal bone screw - locking screw	Tien Tien Trading Company in Tibet	Genesis Medical Devices (China) Co., Ltd.	HCZ06 type	141000640	Tibet Autonomous Region Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
14	Metal bone screw	Harbin Jindi Cheng Tong Trading Co., Ltd.	Changzhou Jian Li Bond Medical Devices Co., Ltd.	HAPQ04 3.5 × 36mm	16.04.20/ 12042080	Heilongjiang Food and Drug Administration	Zhejiang Medical Devices Testing Institute
15	Metal bone screw	Beijing Zhong An Taihua Technology Co., Ltd.	Beijing Zhong An Taihua Technology Co., Ltd.	4.5 * 52 / HAQ03	February 2017 26/1612021	Beijing Food and Drug Administration	Zhejiang Medical Devices Testing Institute
16	Metal bone screw	Beijing Zhong An Taihua Technology Co., Ltd.	Beijing Zhong An Taihua Technology Co., Ltd.	4.5 * 52 / HAQ03	December 12, 2016 1610012	Beijing Food and Drug Administration	Zhejiang Medical Devices Testing Institute
17	Straight bone plate and bone screw system	Stryker (Beijing) Medical Devices Co., Ltd.	Stryker GmbH	340638	00085V	Beijing Food and Drug Administration	Zhejiang Medical Devices Testing Institute
18	Metal bone screw	Shandong Weigao Orthopedic Materials Co., Ltd.	Shandong Weigao Orthopedic Materials Co., Ltd.	3.5 × 36 / HAQ03	2017-05-02/ 170402821	Shandong Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute
19	Metal bone screw	Weihai Starfish Medical Devices Co., Ltd.	Weihai Starfish Medical Devices Co., Ltd.	3.5 × 30 / HAQ03	2017-05-13/ 170400409	Shandong Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute
20	Universal locking metal plate system	Shandong Airlines Wei orthopedic Medical Devices Co., Ltd.	Shandong Airlines Wei orthopedic Medical Devices Co., Ltd.	Bone screw SHASZ06 3.5 * 40	2017-02-03/ 170201	Shandong Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute
21	Metal bone screw	Beijing Zhong An Taihua Technology Co., Ltd.	Beijing Zhong An Taihua Technology Co., Ltd.	4.5 * 52 / HAQ03	September 04, 2016/1607022	Beijing Food and Drug Administration	Zhejiang Medical Devices Testing Institute
22	Metal locking bone screws	Shandong Hong Sing Medical Devices Co., Ltd.	Shandong Hong Sing Medical Devices Co., Ltd.	5.0 × 46 HCZL06	17.05.22/ 3021010250046	Shandong Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute
23	Bone screws	Beijing Bell Biological Engineering Institute Co., Ltd.	Beijing Bell Biological Engineering Institute Co., Ltd.	HBQ03Φ4.0 * 12mm full thread	161215/ 160047666	Beijing Food and Drug Administration	Zhejiang Medical Devices Testing Institute
24	Bone screws	Beijing Bell Biological Engineering Institute Co., Ltd.	Beijing Bell Biological Engineering Institute Co., Ltd.	HAQ03Φ2.7 * 10mm	2016-09-05/ 160035926	Beijing Food and Drug Administration	Zhejiang Medical Devices Testing Institute
25	Self-tapping screw locking (metal locking plate system)	Zhangjiakou Renkang Medical Devices Distribution Co., Ltd.	Tianjin Weiman Biological Materials Co., Ltd.	SHAB0203-01	2017-3-17/ AEV526	Hebei Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute
26	Metal bone screws - common type cortical screws	Zhuhai, Tibet Medical Devices Co., Ltd.	Xiamen big Bo Ying Jing Medical Devices Co., Ltd.	4.5 * 36mm / STQ03-UT	1511040042/ 040040036	Tibet Autonomous Region Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
27	Metal bone screw	Hexi University Affiliated Zhangye City People's Hospital	Jiangsu Jinlu Group Medical Devices Co., Ltd.	HAQ03 4.5 * 48	2013.09.21/ 1309389	Gansu Provincial Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
28	Metal bone screw	Sichuan Jin Qi Trading Company	Changzhou Jian Li Bond Medical Devices Co., Ltd.	HAPQ04 3.5 * 22mm	16.04.13/ 12042073/ 6058322	Sichuan Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
29	Metal bone screw	Shandong Weigao orthopedic Materials Co., Ltd. Chengdu sales branch	Shandong Weigao Orthopedic Materials Co., Ltd.	4.5 * 50 / HAQ03	2016.05.20/ 160400463/ 6134550	Sichuan Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
30	Metal bone screw	Guizhou Hongyuan Tong Electronics Co., Ltd.	Shandong Weigao Orthopedic Materials Co., Ltd.	Model: HAQ03 Specification: 3.5X18	150300193/ 6133518	Guizhou Province Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
31	Metal bone screw	Friends of Shanghai Medical Devices Co., Ltd. three	Friends of Shanghai Medical Devices Co., Ltd. three	HAQ03	170411/ 1703523/ 23940220	Shanghai Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
32	Metal locking bone screws	Friends of Shanghai Medical Devices Co., Ltd. three	Friends of Shanghai Medical Devices Co., Ltd. three	HAZL03	170401/ 1703105/ 25940226	Shanghai Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
33	Bone screws	Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd.	Synthes GmbH	404.030S	June 04, 2015/9521895	Shanghai Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
34	Metal bone screw	Shanghai Pu Wei Medical Devices Co., Ltd.	Shanghai Pu Wei Medical Devices Co., Ltd.	Specifications: 5 * 50 Model: HAS Ⅱ 03	170518/ B17050117	Shanghai Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
35	Anatomical metal locking plate system (locking bone screw)	Qingyang City People's Hospital	Jiangsu Aidier Medical Technology Co., Ltd.	5.0 × 75mm HAWB03 / R	2016.11.07/ 16100497	Gansu Provincial Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
36	Metal bone screw	Qinghai Kester Trading Company	Tianjin Weiman Biological Materials Co., Ltd.	HAQ03-01 4.5 × 30	2016-11-8/ AET318	Qinghai Provincial Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
37	Metal locking bone screws	Chongqing Ai Li Medical Devices Co., Ltd.	Friends of Shanghai Medical Devices Co., Ltd. three	HAZL03 5.0 × 48	140728/ 1404118/ 25940348	Chongqing Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
38	Metal bone screw	Yinchuan million Telford Trading Company	Changzhou Kang Hui Medical Devices Co., Ltd.	HAQ03 φ3.5 * 20	2017.03.02/ 170057319/ 30306120	Ningxia Hui Autonomous Region Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
39	Bone screws	Xi'an God Bless Medical Devices Co., Ltd.	Beijing Bell Biological Engineering Institute Co., Ltd.	HAQ03 Ф3.5 × 40mm	2016-03-30/ 160022146/ B00000179	Shaanxi Provincial Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
40	Bone screws	Xi'an God Bless Medical Devices Co., Ltd.	Beijing Bell Biological Engineering Institute Co., Ltd.	THAQ03 Ф3.5 × 38mm	2016-04-06/ 160021322/ B00000178	Shaanxi Provincial Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
41	Metal bone screws (T) Cortical bone full of mosquito screws	Hainan State Science and Technology Trade Co., Ltd.	Wuhan Germany Si Beier Surgical Implants Co., Ltd.	HA4.5 * 30 HAQ03	2014.01.15/ 1401231	Hainan Province Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
42	Metal bone screw	Yunnan Wenzheng Medical Devices Co., Ltd.	Jiangsu Hundred Easy Medical Technology Co., Ltd.	HAQ03 3.5X20 full thread	2017-02-18/ 216111161	Yunnan Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
43	Metal bone screw	Hainan fast health Pharmaceutical Co., Ltd.	Tianjin Weiman Biological Materials Co., Ltd.	Specifications: 3.5 * 30 Model: HAQ03-01	2015-1-21/ ADX425	Hainan Province Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
44	Metal screw-HA type bone screw	Ningxia Chunxiao Pharmaceutical Co., Ltd.	Changzhou Osmanthus Medical Devices Co., Ltd.	HAQ03 Φ4.5 * 42 spherical (standard) full tooth	20160120/ 151281230	Ningxia Hui Autonomous Region Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
45	Metal bone screw	Guizhou Medical Public Health Investment Co., Ltd.	Jiangsu Aidier Medical Technology Co., Ltd.	Model: HAQ03 / Specifications: 4.5 × 30mm	2016.07.12/ 16070127	Guizhou Province Food and Drug Administration	Guangdong Provincial Medical Device Quality Supervision and Inspection Institute
46	Household potential therapeutic apparatus	White Shou Medical Devices (Suzhou) Co., Ltd.	White Shou Medical Devices (Suzhou) Co., Ltd.	HEF-H9000	/7016H93260	Jiangsu Province Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
47	High potential treatment machine	Shanghai Long Rui Medical Electronics Co., Ltd.	Shanghai Long Rui Medical Electronics Co., Ltd.	LR-YKY-30F	2017-04/ 0453797001	Shanghai Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
48	High potential treatment machine	Shanghai Xingrui Biological Technology Co., Ltd.	Shanghai Xingrui Biological Technology Co., Ltd.	XR-GDW-09B	2017-04/ 0460807002	Shanghai Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
49	High-voltage potential treatment instrument	Shanghai Shan Jian Medical Devices Co., Ltd.	Shanghai Shan Jian Medical Devices Co., Ltd.	GZ-901E	May 2016 10 / 160503	Shanghai Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
50	High potential treatment machine	Shanghai Guanrui Medical Electronics Co., Ltd.	Shanghai Guanrui Medical Electronics Co., Ltd.	GR-GDW-09C	2017-01/ 0160997143	Shanghai Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
51	High potential therapeutic apparatus	Shanghai Yuan Beida An Medical Devices Co., Ltd.	Shanghai Yuan Beida An Medical Devices Co., Ltd.	PZ-100D	/201612024	Shanghai Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
52	Potential therapy device	Beijing Jia Nong Medical Devices Co., Ltd.	MARUTAKATECHNO CO., LTD.	KAVASS	February 16, 17/0800065047	Beijing Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
53	Potential therapy device	Beijing Jia Nong Medical Devices Co., Ltd.	MARUTAKATECHNO CO., LTD.	KAVASS	February 17, 17/2900048317	Beijing Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
54	Cold radiofrequency tumor treatment machine	Zhuhai and good medical equipment Co., Ltd.	Zhuhai and good medical equipment Co., Ltd.	HGCF-3000	May 12, 2017 / N66161100529	Guangdong Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
55	Bipolar / multipolar radiofrequency ablation treatment system	Beijing Bain pharmaceutical technology development limited liability company	Olympus Winter & Ibe GmbH	WB991029	2016-08-04/ B000012	Beijing Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
56	RF tumor ablation system	Beijing Bolaode Optoelectronics Technology Development Co., Ltd.	Beijing Bolaode Optoelectronics Technology Development Co., Ltd.	RFA-Ⅱ	March 20, 2017 / XXL85Y020101	Beijing Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
57	RF temperature control fuser	Xi'an sterilization and disinfection equipment manufacturing company	Xi'an sterilization and disinfection equipment manufacturing company	XJ-08	/081604311	Shaanxi Provincial Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
58	RF fuser	Shenzhen Anke high-tech Co., Ltd.	Shenzhen Anke high-tech Co., Ltd.	ASA-601T	March 2017/1723120701	Guangdong Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
59	Cardiac radiofrequency ablation instrument	Sichuan Jinjiang Electronic Technology Co., Ltd.	Sichuan Jinjiang Electronic Technology Co., Ltd.	HL-100F	April 2017 / XP170409	Sichuan Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center
60	Multi-polar radiofrequency ablation instrument	Mianyang Lide Electronics Co., Ltd.	Mianyang Lide Electronics Co., Ltd.	LDRF-120S	April 10, 2017 / ZB17-1020	Sichuan Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center

food drug Regulatory Authority

January 19, 2018