China Quality News Network Recently, Henan Provincial Drug Administration issued a medical equipment quality announcement (No. 3, 2021). According to the announcement, in order to strengthen the quality supervision and management of medical device and ensure the safety and effective use of medical equipment products, the Henan Provincial Drug Administration organized regulatory departments to supervise and randomly supervise the province’s medical device products. The results of the product sampling inspection that do not meet the standards as follows: as follows:

1. 1 batch of ultrasonic cleansing machines produced by Guilin Woodpecker Medical Device Co., Ltd., specifications: UDS-J, product number: S19A0229J, production date: December 2019, unqualified items: controller operating parts.

2. One batch of ultrasonic dental cleansing machines produced by Nanning Polei Medical Device Co., Ltd., specification models: P5L, product number: 03210326, unqualified items: Equipment or equipment external marks.

3. 1 batch of infrared therap device produced by Chongqing Changle Silicate Co., Ltd., specification models: L-150A, product number: 21030813551, production date: March 8, 2021, unqualified project: use instructions.

4. A batch of electronic thermometers produced by Guangzhou Aicingda Electronics Co., Ltd., specification models: AXD-202, production batch number: 20200405, production date: April 5, 2020, unqualified project: Technical manual.

5. A batch of electronic thermometers produced by Guangzhou Aicingda Electronics Co., Ltd., specification models: AXD-202, production batch number: 20201215003, production date: December 15, 2020, unqualified project: Technical manual.

6. 1 batches of magnetic therapy stickers produced by Zhengzhou Kangjin Rui Health Industry Co., Ltd., specification models: 5cmx5cm; 1 sticker/bag, production batch number: 210410, production date: April 10, 2021, unqualified project: magnetic field strength.

7. Xinxiang Kangbeel Medical Technology Co., Ltd. produced by a batch of disposable use of sterile vaginal dilatators at one time, specification model: push -pull medium number, production batch number: 21020722 production date: February 7, 2021, unqualified project: Epoxyne ethane residual.

8. Henan Hong Ran Medical Device Co., Ltd. produced a batch of one -time use of sterile urinary packages, specification models: 16, production batch number: 2020110258, production date: November 220, 2020 Essence

9. One batch of medical surgical masks produced by Henan Shiweiwei Materials Co., Ltd., specification models: plane type 17.5cmx9.5cm ± 5%, production batch number: 20200920, production date: September 21, 2020, unqualified items: Mask belt, pressure difference (Δp).

10.郑州冉晨医疗器械有限公司生产的1批次一次性使用医用口罩,规格型号:无菌平面耳挂式17.5cmX9.5cm,生产批号:20201029,生产日期:2020年10月30日,不Qualified items: mask straps.

For the above -mentioned products that do not meet the standards of standards, the Henan Provincial Drug Administration has been transferred to the drug supervision and management department of the enterprise in accordance with the procedures to investigate and dispose according to law.

Medical equipment supervision and random inspection do not meet the standard of the product specifications

Serial number

sample name

Inspection unit

Marked the production unit

Specification

Production batch

Sample unit

Inspection agency

Unqualified project

Remark

1

Ultrasonic cleansing machine

Luoyang Qinglong Medical Device Co., Ltd.

Guilin Woodpecker Medical Device Co., Ltd.

UDS-J

/ /

Luoyang Market Supervision and Administration Bureau

Henan Provincial Medical Device Inspection Institute

Controller

Operating part

2

Wuxian County Huamin Medical Device Co., Ltd.

Nanning Polei Medical Device Co., Ltd.

P5L

Jiaozuo Market Supervision and Administration Bureau

Device or device

External label

3

Infrared treatment device

Xiangcheng County People’s Hospital

Chongqing Changle Silicate Co., Ltd.

L-1 150A

Xuchang Market Supervision and Administration Bureau

technical manual

4

Digital Thermometer

Henan Tengban Medical Device Co., Ltd.

Guangzhou Aita Electronics Co., Ltd.

AXD-202

20200405

Anyang Market Supervision and Administration Bureau

5

Jiyuan Good People’s Pharmacy Chain Co., Ltd. Zhouyuan Road Store

20201215003

Jiyuan Market Supervision and Administration Bureau

河南省药品监督管理局医疗器械质量公告(2021年第3期)

6

Magnetic therapy sticker

Zhengzhou Kangjin Rui Health Industry Co., Ltd.

5cmx5cm; 1 post/bag

210410

Henan Provincial Pharmaceutical Supervision Bureau First Supervision Branch

Magnetic field strength

7

Use a sterile vaginal dilatator at one time

Xinxiang Kangbeel Medical Technology Co., Ltd.

Push -pull medium

21020722

The Second Supervision Branch of Henan Pharmaceutical Supervision and Administration Bureau

Ethical ethylene residual volume

8

Use sterile urinary bag at one time

Huaibin County People’s Hospital

Henan Hongran Medical Device Co., Ltd.

16

2020110258

Xinyang Market Supervision and Administration Bureau

Sterile

9

Medical surgical mask

Luyi Zhongshan Hospital

Henan Shiweiwei Material Co., Ltd.

Plane type 17.5cm79.5cm ± 5%

20200920

Luyi County Market Supervision and Administration Bureau

Mask belt, pressure difference (Δp)

10

Use medical masks at one time

Zhengzhou Ranchen Medical Device Company

Sterile plane ear hanging 17.5cm´9.5cm

20201029

Mask

Ultrasonic cleansing machine

/ /

/ /

Henan Provincial Medical Device Inspection Institute

Henan Provincial Medical Device Inspection Institute

Henan Provincial Medical Device Inspection Institute

Henan Provincial Medical Device Inspection Institute

Henan Provincial Medical Device Inspection Institute

Henan Provincial Medical Device Inspection Institute

Henan Provincial Medical Device Inspection Institute

Henan Provincial Medical Device Inspection Institute

Henan Provincial Medical Device Inspection Institute

technical manual

technical manual

Digital Thermometer

Guangzhou Aita Electronics Co., Ltd.

AXD-202

Zhengzhou Kangjin Rui Health Industry Co., Ltd.

Henan Provincial Pharmaceutical Supervision Bureau First Supervision Branch

Xinxiang Kangbeel Medical Technology Co., Ltd.

Zhengzhou Ranchen Medical Device Company