Container, Specimen, Urine, Drugs of Abuse, Over the Counter

Which Manufacturers in China Make This?

6 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Fujian and Shandong, and 1 other province. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Diatrust Medical Co., Ltd. Jiangsu
Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
Hynaut Health Technology Co., Ltd. Shandong, contract manufacturer
K-MED Co., Ltd. Jiangsu
Xiamen Aquatown Technology Co., Ltd. Fujian
Zhejiang Sorfa Life Science Research Co., Ltd. Zhejiang, contract manufacturer

How Is MPQ Classified?

Container, Specimen, Urine, Drugs Of Abuse, Over The Counter is FDA product code MPQ, Class 1, 21 CFR 864.3260.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Container, Specimen, Urine, Drugs Of Abuse, Over The Counter

Container, Specimen, Urine, Drugs of Abuse, Over the Counter

Which Manufacturers in China Make This?

How Is MPQ Classified?

How Does It Reach the US Market?

Xpeedy

Mdhc

Octane Straight IR

Medline

Shark Lumbar Spacer System

Therapak

Ascend

Where China Actually Supplies