Data / Medical devices / China / Gemtier Medical (Shanghai) Inc.
Gemtier Medical (Shanghai) Inc.: FDA-registered device maker in Shanghai, China, 2 510(k) clearances
Gemtier Medical (Shanghai) Inc. is registered with the FDA (registration 3009746425) in Shanghai, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 10, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009746425
- Address
- No. 18, Jianding Road, Fengjing Town, Jinshan District, Shanghai, China, 201502
- Owner or operator
- Gemtier Medical (Shanghai) Inc. (10041480)
- Roles
- Manufacturer
- First device listed
- December 18, 2017
- Registered through
- 2026
- Brand names listed
- RELI, Safety Blood Collection Device for Single Use, Sterile Safety Needle for Single Use, Sterile Syringe for Single Use, Sterile Syringe with Safety needle for Single Use
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | 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 |
|---|---|---|---|---|---|---|
| April 10, 2020 | K192679 | Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use | MEG | Substantially Equivalent | Gemtier Medical (Shanghai), Inc. | accessdata.fda.gov |
| December 11, 2017 | K170276 | Safety Blood Collection Device for Single Use | FMI | Substantially Equivalent | Gemtier Medical (Shanghai), Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Set, Administration, Intravascular
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
Updated April 10, 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.