Contec

Urinalysis Strips

Registry build 21.09.26
10manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jilin (5), Zhejiang (2), Guangxi (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JMA
Manufacturer City Province Registered as Device types
Zhejiang Orient Gene Biotech Huzhou Zhejiang Contract manufacturer 86
Acon Biotech (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 29
Urit Medical Electronic Co., Ltd. Guilin Guangxi Contract manufacturer 28
Weihai Kangzheng Medical Equipments Technology Co., Ltd. Weihai Shandong Contract manufacturer 26
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84
Changchun Wancheng BIO-Electron Co., Ltd. Changchun Jilin Contract manufacturer 34
Changchun Merydi BIO-Tech Co., Ltd. Changchun Jilin Manufacturer 24
Jilin Hongyi BIO-Tech Co., Ltd. Changchun Jilin Manufacturer 24
AVE Science & Technology Co., Ltd. Changsha Hunan Manufacturer 22
Changchun LYZ Technology Co., Ltd. Changchun Jilin Manufacturer 16

Record

Regulatory record for Contec
Listed by Contec Medical Systems Co., Ltd., China
FDA product code JMA
Device type Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Device class Class 1
Regulation 21 CFR 862.1095
Establishment Manufacturer
Record published 2019-09-10
Record revised 2022-11-28 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for Contec
Catalogue number Size Status
URS-11T In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Accessorie Chromsystems Instruments & Chemicals Gmbh 3
Reagent Chromsystems Instruments & Chemicals Gmbh 2
Reagent Kit Chromsystems Instruments & Chemicals Gmbh 2
Ucare 11 Stick YD Diagnostics 1
Rapid Response Btnx Inc. 1
Vitamin C (Ascorbic Acid) DRG Instruments Gesellschaft mit beschränkter Haftung 1
Vitamin C (Ascorbic Acid) DRG International, Inc. 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer