Food and Drug Administration sampling: 6 enterprises 10 medical device products unqualified

Chinese quality news in September 26th, the State Food and Drug Administration released the official website of national medical devices Quality Bulletin (2017 twenty-second, total fortieth), notice the quality supervision of the infrared radiation treatment equipment, ultrasonic physiotherapy equipment of 2 varieties of 44 products sampling.

Among them, the sampling items are not up to standard medical device products, involving 6 medical device manufacturers of 2 varieties, 10 units. Specifically:

(1) infrared radiation treatment equipment 3 enterprises, 7 products. 1 sets of special electromagnetic wave therapy of Chongqing SHUSHUI instrument factory production, the surface of the heater temperature error does not meet the standard requirements; Guiyang Longquan medical instrument limited company to produce 5 sets of special electromagnetic wave therapy, Sichuan Heng Ming Technology Development Company Limited production of 1 sets of specific electromagnetic spectrum treatment device, the heater surface temperature uniformity meet the standard requirements.

(two) ultrasonic physiotherapy equipment 3 enterprises, 3 products. 1 sets of ultrasonic conductance instrument Chengdu Kangfu Scientific Instruments Co. Ltd., protective earthing, grounding function and potential equalization, power supply, network components and wiring does not meet the standard requirements; Italy Amy company (EMILDUE S.R.L) 1 sets of ultrasonic therapy instrument production (agent: Beijing Jin Hao Trading Co., Ltd.) the input power, does not meet the standard requirements; Kang Luoyang medical instrument limited company to produce 1 sets of ultrasonic therapeutic apparatus, normal working temperature under continuous leakage current does not meet the standard requirements.

By sampling to identify the labels and instructions and other projects do not meet the standard requirements of medical products, involving 1 types of 1 medical equipment manufacturing enterprises 5, specifically:

Infrared radiation treatment equipment 1 enterprises, 5 products. Guiyang Longquan Medical Equipment Co., Ltd. produces 5 sets of specific electromagnetic wave therapeutic equipment, equipment or equipment parts of the external marking does not meet the standards.

The sampling items are in line with the standard medical equipment products, involving 26 medical instruments manufacturers and 2 varieties of 34 units.

The State Food and drug administration has requested that the food and Drug Administration of the place where the products, enterprises and agents are located shall not be in conformity with the standards, and the relevant enterprises shall be investigated and dealt with. And asked the relevant provincial food and Drug Administration in a timely manner to dispose of the situation to the public.

The national medical equipment sampling does not meet the standard requirements of
Serial number
Mark product name
Spot check unit
Designated production enterprise
Specification model
Production date / factory number
Sampling unit
Inspection unit
Not up to standard
One
Specific electromagnetic wave therapy apparatus
Kunshan Da Hui Da Da pharmacy Co., Ltd.
Chongqing Shu water Instrument Factory
CQS-20-T
August 2014 2014081574
Jiangsu food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Heater surface temperature error
Two
Specific electromagnetic wave therapy apparatus
Guiyang Longquan Medical Instrument Co., Ltd.
Guiyang Longquan Medical Instrument Co., Ltd.
LQ-2008EQ
2016.05.14

One hundred and sixty million five hundred and one thousand five hundred and one
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Heater surface temperature nonuniformity
Three
Specific electromagnetic wave therapy apparatus
Guiyang Longquan Medical Instrument Co., Ltd.
Guiyang Longquan Medical Instrument Co., Ltd.
LQ-2008A
2016.05.14

One hundred and sixty million five hundred and two thousand and one
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Heater surface temperature nonuniformity
Four
Specific electromagnetic wave therapy apparatus
Guiyang Longquan Medical Instrument Co., Ltd.
Guiyang Longquan Medical Instrument Co., Ltd.
LQ-2008AH
2016.05.14

One hundred and sixty million five hundred and one thousand and one
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Heater surface temperature nonuniformity
Five
Specific electromagnetic wave therapy apparatus
Guiyang Longquan Medical Instrument Co., Ltd.
Guiyang Longquan Medical Instrument Co., Ltd.
LQ-2008CH
2016.05.14

One hundred and sixty million five hundred thousand five hundred and one
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Heater surface temperature nonuniformity
Six
Specific electromagnetic wave therapy apparatus
Guiyang Longquan Medical Instrument Co., Ltd.
Guiyang Longquan Medical Instrument Co., Ltd.
LQ-2008C
Two thousand and sixteen point zero five.14

One hundred and sixty million five hundred thousand one hundred and ninety-nine
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Heater surface temperature nonuniformity
Seven
Specific electromagnetic spectrum therapeutic apparatus
Sichuan Heng Ming Technology Development Co., Ltd.
Sichuan Heng Ming Technology Development Co., Ltd.
TDP-L3
/3160503540
Sichuan food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Heater surface temperature nonuniformity
Eight
Ultrasonic conductivity therapeutic apparatus
Chengdu Kang Fu Scientific Instrument Co., Ltd.
Chengdu Kang Fu Scientific Instrument Co., Ltd.
ZCD-S1
2016 03, 24; ZCDS1 20160022
Sichuan food and Drug Administration
Hubei medical instrument quality supervision and Inspection Center
1. protection earthing, function earthing and potential equalization. 2. network power supply, components and wiring
Nine
Ultrasonic therapeutic apparatus
Beijing Golden Trade Co., Ltd.
Italy S.R.L (EMILDUE) (agent: Beijing Jin Hao Trading Company)
US 13
2014: US061874
Beijing food and Drug Administration
Tianjin medical instrument quality supervision and Inspection Center
Input power
Ten
Ultrasonic therapeutic apparatus
Luoyang Kang Li medical instruments Co., Ltd.
Luoyang Kang Li medical instruments Co., Ltd.
Type LHZ-300
/9303020G01
Henan food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Continuous leakage current at normal operating temperature
 

National medical devices sampling (identification tag specification etc.) the product does not meet the standard list of

Serial number
Mark product name
Spot check unit
Designated production enterprise
Specification model
Production date / factory number
Sampling unit
Inspection unit
Not up to standard
One
Specific electromagnetic wave therapy apparatus
Guiyang Longquan Medical Instrument Co., Ltd.
Guiyang Longquan Medical Instrument Co., Ltd.
LQ-2008EQ
2016.05.14

One hundred and sixty million five hundred and one thousand five hundred and one
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
External marking of equipment or equipment parts
Two
Specific electromagnetic wave therapy apparatus
Guiyang Longquan Medical Instrument Co., Ltd.
Guiyang Longquan Medical Instrument Co., Ltd.
LQ-2008A
2016.05.14

One hundred and sixty million five hundred and two thousand and one
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
External marking of equipment or equipment parts
Three
Specific electromagnetic wave therapy apparatus
Guiyang Longquan Medical Instrument Co., Ltd.
Guiyang Longquan Medical Instrument Co., Ltd.
LQ-2008AH
2016.05.14

One hundred and sixty million five hundred and one thousand and one
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
External marking of equipment or equipment parts
Four
Specific electromagnetic wave therapy apparatus
Guiyang Longquan Medical Instrument Co., Ltd.
Guiyang Longquan Medical Instrument Co., Ltd.
LQ-2008CH
2016.05.14

One hundred and sixty million five hundred thousand five hundred and one
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
External marking of equipment or equipment parts
Five
Specific electromagnetic wave therapy apparatus
Guiyang Longquan Medical Instrument Co., Ltd.
Guiyang Longquan Medical Instrument Co., Ltd.
LQ-2008C
Two thousand and sixteen point zero five.14

One hundred and sixty million five hundred thousand one hundred and ninety-nine
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
External marking of equipment or equipment parts
 

The national medical equipment sampling conform to the standard list of products: Serial number
Mark product name
Spot check unit
Designated production enterprise
Specification model
Production date / factory number
Sampling unit
Inspection unit
One
Infrared polarization therapeutic apparatus
Guangzhou longzhijie Technology Co., Ltd.
Guangzhou longzhijie Technology Co., Ltd.
LGT-3600A
/3600A001400029
Guangdong food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Two
Infrared polarization therapeutic apparatus
Zhuhai dark horse Medical Instrument Co., Ltd.
Zhuhai dark horse Medical Instrument Co., Ltd.
K1
In 2016 04
1A00K1VD03500
Guangdong food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Three
Infrared ray therapy apparatus
Guiyang Huaxin medical instrument limited company
Chongqing Changle silicate Co., Ltd.
T-100A
October 12, 2015:   CQG151000128
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Four
Specific electromagnetic wave therapy apparatus
Guizhou medical treatment equipment Co., Ltd.
Chongqing yidiao Medical Devices Co.
YN-18 desktop small head
2015.08

One million five hundred and eight thousand three hundred and eighty-nine
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Five
Specific electromagnetic wave therapy apparatus
Central medicine store, Second People's Hospital of Huaian pharmacy Co., Ltd.
Chongqing Runyang medical equipment limited liability company
TDP-CQ-15
November 2013: 1531112041B
Jiangsu food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Six
Specific electromagnetic wave therapy apparatus
Nanming Guiyang District Medical Devices Sales Department
Chongqing space rocket Electronic Technology Co., Ltd.
CQ-10
201601

003230
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Seven
Infrared ray therapeutic apparatus
Xuzhou sky fly Electronic Equipment Co., Ltd.
Xuzhou sky fly Electronic Equipment Co., Ltd.
TF-6002
2016.4

Sixty-two billion one hundred and forty million seven hundred and thirty-three thousand six hundred and three
Jiangsu food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Eight
Specific electromagnetic wave therapy apparatus
Guizhou Xiangrui medical instrument limited company
Chongqing Runyang medical equipment limited liability company
TDP-CQ-15
/1550720060B
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Nine
Infrared therapeutic apparatus
Guizhou Qianjiang Medical Instrument Co., Ltd.
Chongqing City Medical Instruments Co., Ltd.
HW-T-1
/1505290034993
Guizhou food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Ten
Specific electromagnetic wave therapy apparatus
Nanning Sanke medical equipment limited liability company
Nanning Sanke medical equipment limited liability company
SK-102
03 May 2016: One million six hundred and five thousand and one
The Guangxi Zhuang Autonomous Region food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Eleven
Infrared ray therapy apparatus
Guangzhou Hao Hao Medical Technology Co., Ltd.
Chongqing space rocket Electronic Technology Co., Ltd.
CQ-30
Two thousand and sixteen.05/
Guangdong food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Twelve
Infrared polarization therapeutic apparatus
Zhuhai Kang Jia medical instruments Co., Ltd.
Zhuhai Kang Jia medical instruments Co., Ltd.
CZ-660I
20160506

116E372
Guangdong food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Thirteen
TDP therapy apparatus
Liuzhou Yida Medical Instrument Co., Ltd.
Chongqing City Medical Instruments Co., Ltd.
TDP-T-I— 1
/1511093013370
The Guangxi Zhuang Autonomous Region food and Drug Administration
Zhejiang medical apparatus Inspection Institute
Fourteen
TDP specific electromagnetic wave therapy apparatus
Chongqing Xinyi medical instrument limited company
Chongqing Xinyi medical instrument limited company
TDP-XY-10X
May 16, 2016 /
Chongqing food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Fifteen
Specific electromagnetic wave therapy apparatus
Chongqing yidiao Medical Devices Co.
Chongqing yidiao Medical Devices Co.
YN-18 desktop small head
2016.05

One hundred and sixty thousand five hundred and twenty-one
Chongqing food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Sixteen
Infrared therapeutic apparatus
Chongqing City Medical Instruments Co., Ltd.
Chongqing City Medical Instruments Co., Ltd.
HW-T-1
2016.5.10 1605100009369
Chongqing food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Seventeen
Infrared ray therapy apparatus
Chongqing Changle silicate Co., Ltd.
Chongqing Changle silicate Co., Ltd.
L-100A
20160420

One hundred and sixty million four hundred thousand nine hundred and seventy-four
Chongqing food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Eighteen
Infrared ray therapy apparatus
Chongqing Warren Hongli Industry Co., Ltd.
Chongqing Warren Hongli Industry Co., Ltd.
HLH-1
May 18, 2016 116001
Chongqing food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Nineteen
Specific electromagnetic wave (TDP) therapy apparatus
Chongqing Yi Qing medical instrument limited company
Chongqing Yi Qing medical instrument limited company
CQ-1θ A
May 6, 2016 YQ160506006
Chongqing food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Twenty
Specific electromagnetic wave therapy apparatus
Zhumadian Watson Medical Instrument Co., Ltd.
Chongqing space rocket Electronic Technology Co., Ltd.
CQ-25
January 2016 /
Henan food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Twenty-one
Infrared therapeutic apparatus
Chongqing Runyang medical equipment limited liability company
Chongqing Runyang medical equipment limited liability company
HWY-15
2016, 05, 1560535001
Chongqing food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Twenty-two
Infrared ray therapy apparatus
Chongqing space rocket Electronic Technology Co., Ltd.
Chongqing space rocket Electronic Technology Co., Ltd.
CQ-61
2016.05

007619
Chongqing food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Twenty-three
Infrared therapeutic apparatus
Chongqing Kang Kang brand medical instruments Co., Ltd.
Chongqing Kang Kang brand medical instruments Co., Ltd.
KHL-2
2016.5.18

Eight hundred and sixteen thousand and one
Chongqing food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Twenty-four
Infrared therapeutic apparatus
Chongqing Feng Feng Machinery Co., Ltd.
Chongqing Feng Feng Machinery Co., Ltd.
PF-LJ-100 (vertical)
20160503 PF00160501002
Chongqing food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Twenty-five
Specific electromagnetic wave therapy apparatus
Chongqing Zhongzhi Medical Instrument Co., Ltd.
Chongqing Zhongzhi Medical Instrument Co., Ltd.
CQ-BS6
2016-5-30

160530H
Chongqing food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Twenty-six
Ultrasonic therapeutic apparatus
Shenzhen Technology Co., Ltd.
Shenzhen Technology Co., Ltd.
DM-200B
Two thousand and fifteen point six.3

Two hundred and one billion five hundred and six million thirty thousand and five
Guangdong food and Drug Administration
Hubei medical instrument quality supervision and Inspection Center
Twenty-seven
Ultrasonic instrument for uterine involution
Chongqing Pacific Medical Polytron Technologies Inc
Chongqing Pacific Medical Polytron Technologies Inc
CKC100
In 2016 05
One hundred and fifty thousand one hundred and forty-nine
Chongqing food and Drug Administration
Hubei medical instrument quality supervision and Inspection Center
Twenty-eight
Ultrasonic conductivity meter
Beijing Noah TongZhou Medical Technology Co Ltd
Beijing Noah TongZhou Medical Technology Co Ltd
NAVA-01 TD
2016.05.20

Three hundred and sixteen million thirty-three thousand four hundred and seventy-six
Beijing food and Drug Administration
Tianjin medical instrument quality supervision and Inspection Center
Twenty-nine
Ultrasonic conductivity prostate therapeutic apparatus
Nanjing early spring medical instruments Co., Ltd.
Nanjing early spring medical instruments Co., Ltd.
ZC-8800B
/1408307
Jiangsu food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Thirty
Ultrasonic conductivity therapeutic apparatus
Nanjing winner Electronics Co., Ltd.
Nanjing winner Electronics Co., Ltd.
Type AKS-802
/821507006
Jiangsu food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Thirty-one
Aluoc Series Ultrasonic Deep therapeutic apparatus
Xuzhou allock medical electronic equipment Co. Ltd.
Xuzhou allock medical electronic equipment Co. Ltd.
Aluoc-770
Two thousand and sixteen.5

A75121612T
Jiangsu food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Thirty-two
Ultrasonic therapeutic apparatus
Suzhou best medical instrument Co., Ltd.
Suzhou best medical instrument Co., Ltd.
HB810D
/160406101
Jiangsu food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Thirty-three
Ultrasonic therapeutic apparatus
Wuhan HEMPEL medical instruments Co., Ltd.
Wuhan HEMPEL medical instruments Co., Ltd.
U-C-Hz-80
201605

000171
Hubei food and Drug Administration
Anhui Provincial Institute of food and drug inspection
Thirty-four
Ultrasonic therapeutic apparatus
Shenzhen lucky Hi Tech Co., Ltd.
Shenzhen lucky Hi Tech Co., Ltd.
838A-H-L-S
2015-12-31

A-SX15122501
Guangdong food and Drug Administration
Guangdong medical instruments quality supervision and Inspection Institute