Data / Medical devices / China / Assure Tech. (hangzhou) Co., Ltd.

Assure Tech. (hangzhou) Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 18 510(k) clearances

Assure Tech. (hangzhou) Co., Ltd. is registered with the FDA (registration 3009585529) in Hangzhou Zhejiang, China. It lists 48 device types. The FDA files 18 510(k) clearances under its listings, the newest dated June 5, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

3009585529

Address

Building 4, No. 1418-50, Moganshan Road, Gongshu District, Hangzhou Zhejiang, China, 310011

Owner or operator

Assure Tech. (Hangzhou) Co., Ltd. (10040710)

Roles

Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer

First device listed

July 31, 2012

Registered through

2026

Brand names listed

ASSURETECH DOA DIPSTICK SCREEN PANEL TESTS, ASSURETECH DOA INTEGRATED CUP TESTS, Areta Cocaine Test Strip (ASCOC-114), Areta Cotinine Test Strip, ASCOT-114C, Areta Marijuana Test Strip, ASTH-114C, Areta Multi-Drug Screen Test, ADTP-1124, Areta Multi-Drug Screen Test, ADTP-254, Areta Multi-Drug Screen Test, ADTP-3104 and more

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

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Updated June 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.