Hangzhou Aichek Medical Technology Co., Ltd.
Country not established FDA
- Devices
- 11
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Hangzhou Aichek Medical Technology Co., Ltd. makes
The company produces rapid in vitro diagnostic (IVD) devices for detecting multiple drugs of abuse, including test cups and panel kits designed for clinical and point-of-care use. These products are intended for immediate, on-site screening to identify substances such as opioids, cocaine, amphetamines, and benzodiazepines in human samples. The devices are formatted for quick, single-use testing, supporting both qualitative and semi-quantitative results.
The portfolio consists of Class II medical devices, regulated under the FDA’s Unique Device Identification (UDI) system. These products are listed in the FDA’s UDI database, adhering to U.S. regulatory requirements for diagnostic testing. The manufacturer operates from the United States, ensuring compliance with domestic medical device regulations.
Catalogue
Search and filter all 11 devicesCompany details
- DUNS number
- 548416054
FDA establishments
- Hangzhou Aichek Medical Technology Co., Ltd. Hangzhou Zhejiang · CN FEI 3025349997
Frequently asked questions
How many devices does Hangzhou Aichek Medical Technology Co., Ltd. have in the registry?
The registry currently lists 11 devices for Hangzhou Aichek Medical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hangzhou Aichek Medical Technology Co., Ltd.'s devices?
Among its 11 most recently registered devices, Hangzhou Aichek Medical Technology Co., Ltd. has devices listed in FDA GUDID (11 devices).
What risk classes do Hangzhou Aichek Medical Technology Co., Ltd.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Hangzhou Aichek Medical Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hangzhou Aichek Medical Technology Co., Ltd. in the registry?
The most recently registered devices listed for Hangzhou Aichek Medical Technology Co., Ltd. include SnapCheckDx Rapid Urine THC Test 1, Pocguide Multi-Drug Test Cup 1, Pocguide Multi-Drug Test Panel 1 and Pocguide Multi-Drug Test Cup OTC 1.
Which FDA establishments are linked to Hangzhou Aichek Medical Technology Co., Ltd.?
1 FDA establishment is linked to Hangzhou Aichek Medical Technology Co., Ltd. in the registry; they are listed on the company page.