Data / Medical devices / China / Microtech Medical (hangzhou) Co., Ltd.
Microtech Medical (hangzhou) Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 1 510(k) clearance
Microtech Medical (hangzhou) Co., Ltd. is registered with the FDA (registration 3014302067) in Hangzhou Zhejiang, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 11, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014302067
- Address
- No.108 Liuze St., Yuhang District, Hangzhou Zhejiang, China, 311121
- Owner or operator
- MicroTech Medical (Hangzhou) Co., Ltd. (10074553)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 18, 2020
- Registered through
- 2026
- Brand names listed
- Gochek2 Blood Glucose Monitoring System; Gochek2 Connect Blood Glucose Monitoring System; Pancares App
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2020 | K193340 | GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System | NBW | Substantially Equivalent | Microtech Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 11, 2020. 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.