State Food and Drug Administration: 54 batches of medical devices were unqualified

Medical Network July 24th This sampling, the number of medical device products that do not meet the standard requirements, has reached 54 batches.

Yesterday (July 23), country drug The Authority issued the country medical instruments Notice of Supervising the Results of the Sampling (No. 5). The notice stated that the former State Food and Drug Administration organized 252 batches (sets) of 7 varieties of artificial lenses, respiratory catheters (sucking tubes) and light therapy equipment. The product has undergone quality supervision and sampling, a total of 54 batches (sets) of products are not in conformity standard Provision.

The relevant information specified in the non-regulation standards is as follows:

National medical device sampling inspection does not meet the standard list of products

Label product name	Label production company	Does not meet the standard requirements
Heparin surface treatment of hydrophilic acrylic intraocular lens	HexaVision SARL	1. Size and tolerance (total diameter, body diameter); 2. Spectral transmittance
Injectable multifocal hydrophilic acrylic intraocular lens	Rayner Intraocular Lenses Limited	Power
Intraocular lens	Lenstec (Barbados) Inc	Power
Intraocular lens	Bausch & Lomb Inc.	Power
Slit lamp microscope	Suzhou Kangjie Medical Co., Ltd.	Left, right view system magnification tolerance
KJ5DII digital image processing system slit lamp microscope	Suzhou Kangjie Medical Co., Ltd.	input power
Slit lamp microscope	Chongqing Yuanshi Technology Co., Ltd.	The amount of movement of the object when zooming
Slit lamp microscope	Suzhou Bangqiao Medical Devices Co., Ltd.	Microscope total magnification tolerance
Carbon dioxide laser treatment machine	Guangzhou Laser Technology Application Research Institute Co., Ltd.	Control device and instrument accuracy
Carbon dioxide laser treatment machine	Hubei Kangda Pharmaceutical Development Co., Ltd.	Control device and instrument accuracy
Carbon dioxide laser treatment machine	Shanghai Debang Deli Laser Technology Co., Ltd.	1. Control device and instrument accuracy; 2. Key controller; 3. Laser wavelength
Carbon dioxide laser treatment machine	Chengdu Guoxiong Photoelectric Technology Co., Ltd.	1. Protection grounding impedance; 2. Control device and instrument accuracy
Carbon dioxide laser treatment instrument	Shanghai Hao Photoelectric Technology Co., Ltd.	1. Input power; 2. Control device and instrument accuracy
Carbon dioxide laser treatment instrument	Shanghai Jiading Photoelectric Instrument Co., Ltd.	1. Control device and instrument accuracy; 2. Laser wavelength
Carbon dioxide laser treatment instrument	Shanghai Jiading Photoelectric Instrument Co., Ltd.	1. Control device and instrument accuracy; 2. Laser wavelength
Carbon dioxide laser treatment machine	Hefei Anheng Photoelectric Co., Ltd.	Laser pulse (string) terminal output energy and power
Baby blue light therapy device	Zhengzhou Disheng Instrument Co., Ltd.	Maximum bilirubin irradiance
LED blue light therapy device	Henan Ruichang Medical Device Manufacturing Co., Ltd.	Maximum bilirubin irradiance
Jaundice treatment instrument	Natus Medical Incorporated	distributed
Red and blue therapeutic apparatus	Wuhan Jiutou Bird Medical Instrument Development Co., Ltd.	Timing
SS-series red light medical instrument	Wuxi Nanyang Optical Electronics Co., Ltd.	1. Terminal output power (density) / energy (density); 2. Timing time
Photon skin rejuvenation instrument	Shenzhen Jisidi Technology Co., Ltd.	1. Terminal output power (density) / energy (density); 2. Pulse width
Photon skin rejuvenation instrument	Hubei Kangda Pharmaceutical Development Co., Ltd.	Terminal output power (density) / energy (density)
NM-series photon therapy device	Wuxi Nanyang Optical Electronics Co., Ltd.	Terminal output power (density) / energy (density)
Intense pulse light therapy	Beijing Kangding Medical Technology Co., Ltd.	1. Input power; 2. Terminal output power (density) / energy (density); 3. Pulse width
Ultraviolet light therapy device	Runchang United (Beijing) Medical Equipment Co., Ltd.	Ultraviolet radiation intensity error
Disposable sterile suction tube	Beijing Hongxiang Poly Electronics Co., Ltd.	Actual length of the pipe
Disposable sterile suction tube	Beijing Hongxiang Poly Electronics Co., Ltd.	Vacuum control unit
Disposable sterile suction tube	Zhanjiang Shida Industrial Co., Ltd.	Vacuum control unit
Single use suction bag	Suzhou Riyuexing Plastic Co., Ltd.	Vacuum control unit
Single use combination suction tube	Zhejiang Lingyang Medical Equipment Co., Ltd.	Vacuum control unit
Single use combination suction tube	Zhejiang Lingyang Medical Equipment Co., Ltd.	Vacuum control unit
Single use suction tube	Guangdong Longxin Medical Equipment Co., Ltd.	End hole diameter
Low frequency therapy device	Shenzhen Dongjilian Electronics Co., Ltd.	1. Continuous leakage current and patient auxiliary current; 2. Patient connector; 3. Random file; 4. Accuracy of working data
Low and medium frequency comprehensive therapeutic apparatus	Guangzhou Citizen Electronic Technology Co., Ltd.	Patient connector
Intermediate frequency therapy device	Beijing Dongjie Hua Medical Medical Equipment Co., Ltd.	1. Random file; 2. Power supply voltage fluctuation
Warm medium and low frequency therapeutic apparatus	Wuhan Kangbenlong Medical Equipment Co., Ltd.	random document
Warm medium and low frequency therapeutic apparatus	Wuhan Kangbenlong Medical Equipment Co., Ltd.	random document
Low frequency therapy device	Guangzhou Aokewei Electronics Co., Ltd.	random document
Ultrasonic low intermediate frequency conductance therapy instrument	Guangzhou Aishengwei Pharmaceutical Technology Co., Ltd.	Accuracy of work data
EEG biomimetic stimulator	Shanghai Gankang Medical Technology Co., Ltd.	Accuracy of work data
Low and medium frequency multi-function therapeutic apparatus	Guangzhou Kepeng Electronics Co., Ltd.	input power
Cerebral circulatory system therapeutic apparatus	Shanghai Melaleuca Medical Equipment Co., Ltd.	The sample does not work properly during normal inspection
Digital electronic thermometer	Dongguan Xinlu Medical Technology Co., Ltd.	random document
Digital Thermometer	Jiaxing Yikang Biotechnology Co., Ltd.	1. Display range; 2. Low temperature and over temperature prompt function
Medium frequency electronic pulse therapy instrument	Guangzhou Yanghe Biotechnology Co., Ltd.	Accuracy of work data

National medical device sampling (identification of labeling instructions, etc.) List of products that do not meet the standard requirements

Label product name	Label production company	Does not meet the standard requirements
Slit lamp microscope	Suzhou Bangqiao Medical Devices Co., Ltd.	External mark
KJ5DII digital image processing system slit lamp microscope	Suzhou Kangjie Medical Co., Ltd.	External mark
Carbon dioxide laser treatment machine	Shanghai Debang Deli Laser Technology Co., Ltd.	mark
Carbon dioxide laser treatment instrument	Shanghai Hao Photoelectric Technology Co., Ltd.	External marking of equipment or equipment parts
Intense pulse light therapy	Beijing Kangding Medical Technology Co., Ltd.	1. External marking of equipment or equipment parts; 2. Instruction manual; 3. Technical specification
PKHGY-I red light therapy device	Hebei Pu Kang Medical Equipment Co., Ltd.	1. External marking of equipment or equipment parts; 2. Technical specification
Neonatal Blu-ray treatment machine	Shanghai Siling Medical Thermostat Equipment Co., Ltd.	External marking of equipment or equipment parts
Neonatal jaundice treatment bed	Suzhou Beiyin Medical Devices Co., Ltd.	External marking of equipment or equipment parts
Red light therapy device	Hebei Formis Medical Equipment Trading Co., Ltd.	External marking of equipment or equipment parts
SS-series red light medical instrument	Wuxi Nanyang Optical Electronics Co., Ltd.	External marking of equipment or equipment parts
NM-series photon therapy device	Wuxi Nanyang Optical Electronics Co., Ltd.	External marking of equipment or equipment parts
Photon skin rejuvenation instrument	Hubei Kangda Pharmaceutical Development Co., Ltd.	1. Instruction manual; 2. Technical specification
Ultraviolet light therapy device	Runchang United (Beijing) Medical Equipment Co., Ltd.	user's Guide
Intermediate frequency therapy device	Beijing Dongjie Hua Medical Medical Equipment Co., Ltd.	External marking of equipment or equipment components (GB9706.1-2007 6.1)
Computer IF Meridian therapy device (trade name: digital multi-function therapy device)	Guangzhou Qiaoxin Medical Device Technology Development Co., Ltd.	External marking of equipment or equipment components (GB9706.1-2007 6.1)
Computer intermediate frequency meridian treatment instrument	Guangzhou Qiaoxin Medical Device Technology Development Co., Ltd.	External marking of equipment or equipment components (GB9706.1-2007 6.1)
Computer intermediate frequency meridian treatment instrument	Guangzhou Qiaoxin Medical Device Technology Development Co., Ltd.	External marking of equipment or equipment components (GB9706.1-2007 6.1)
Low and medium frequency comprehensive therapeutic apparatus	Guangzhou Citizen Electronic Technology Co., Ltd.	External marking of equipment or equipment components (GB9706.1-2007 6.1), external marking of equipment or equipment components (YY 0607-2007 6.1)
Digital Thermometer	Dongguan Haokang Electronic Technology Co., Ltd.	External marking of equipment or equipment parts