Data / Medical devices / China / Vamed Medical Instrument Co.,ltd
Vamed Medical Instrument Co.,ltd: FDA-registered device maker in Foshan Guangdong, China, 2 510(k) clearances
Vamed Medical Instrument Co.,ltd is registered with the FDA (registration 3002806999) in Foshan Guangdong, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 28, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002806999
- Address
- 1 of 8 Floor, 2# Building, No. 60,Langbao West Road,Chancheng District, Foshan Guangdong, China, 528000
- Owner or operator
- Vamed Medical Instrument Co.,Ltd (10079580)
- Roles
- Manufacturer
- First device listed
- December 14, 2020
- Registered through
- 2026
- Brand names listed
- ECP-MC3, Soulaire
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Counter-Pulsating, External | DRN | 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 |
|---|---|---|---|---|---|---|
| August 28, 2020 | K202108 | External Counterpulsation System, Soulaire | DRN | Substantially Equivalent | Vamed Medical Instrument Co., Ltd. | accessdata.fda.gov |
| September 10, 2019 | K190683 | External Counterpulsation System | DRN | Substantially Equivalent | Vamed Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 28, 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.