 Home > Biochemistry News > Biotechnology News > NMPA released the results of the national medical device supervision and sampling: 26 batches of products did not meet the standard requirements

NMPA released the results of the national medical device supervision and sampling: 26 batches of products did not meet the standard requirements

 Last Update: 2021-12-02
 Source: Internet
 Author: User

Tags

infant hair products

mandelic acid products

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

On November 17, the State Food and Drug Administration issued a notice on the results of the National Medical Device Supervision Sampling Inspection ((No.

In order to strengthen the supervision and management of medical devices and ensure the quality, safety and effectiveness of medical device products, the National Medical Products Administration organized a random inspection of the product quality of 14 varieties including semiconductor laser treatment machines, high-frequency surgical equipment, and synthetic resin teeth, with a total of 26 batches ( Taiwan) The product does not meet the standard requirements

(1) One semiconductor laser treatment machine: produced by Wuhan Love Technology Co.

(2) One carbon dioxide laser therapy machine: produced by Changchun Dimei Optoelectronics Technology Co.

(3) Two sets of high-frequency surgical equipment: produced by Hangzhou Dedao Medical Equipment Technology Co.

(4) One batch of synthetic resin teeth: produced by Shanxi Changzhi Dental Materials Co.

(5) One endoscope washer-disinfector: produced by Guangzhou Meimei Medical Technology Co.

(6) One batch of soft contact lenses: produced by MI GWANG CONTACT LENS CO.

(7) One nerve and muscle stimulator: produced by Harbin Guoji Xiangyun Medical Apparatus Co.

(8) Seven batches of surgical gowns: Jiangsu Weihu Medical Technology Co.

Breaking strength-dry state (critical area of the product), breaking strength-wet state (critical area of the product) do not meet the standard requirements

(9) 1 set of sleep apnea treatment equipment: produced by Suzhou Anmeng Medical Equipment Co.

(10) 4 gastric lavage machines: produced by Harbin Dapeng Medical Equipment Co.

(11) Two electrocardiographs: produced by Henan Yunxin Network Technology Co.

(12) One batch of disposable human venous blood sample collection needles, produced by Guangzhou Yangpu Medical Technology Co.

(13) Two intermediate frequency electrotherapy instruments: produced by Beijing Dongjiehua Medical Equipment Co.
, Ltd.
and Beijing Tianchangfu Medical Equipment Manufacturing Co.
, Ltd.
, involving continuous leakage current at normal operating temperature and patient auxiliary current, and input power does not meet Standard requirements
.

(14) One batch of natural latex rubber condoms: marked as produced by Shandong Yaqi Latex Technology Co.
, Ltd.
, and the blasting volume and pressure do not meet the standard requirements
.

This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.