Data / Medical devices / China / Omay(guangzhou) Med Technologies Co., Ltd
Omay(guangzhou) Med Technologies Co., Ltd: FDA-registered device maker in Guangzhou Guangdong, China, 1 510(k) clearance
Omay(guangzhou) Med Technologies Co., Ltd is registered with the FDA (registration 3028606342) in Guangzhou Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 5, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3028606342
- Address
- Room 501 and Room 302,No.600-1,Guangshan 2nd Road,Fenghuang Streat,Tianhe Dist., Guangzhou Guangdong, China, 510000
- Owner or operator
- Omay(Guangzhou) Med Technologies Co., Ltd (10089276)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
- First device listed
- November 22, 2023
- Registered through
- 2026
- Brand names listed
- NovaHeart
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Counter-Pulsating, External | DRN | 2 | Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 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 5, 2020 | K191955 | Enhanced External Counter Pulsation Device Plus Omay-A | DRN | Substantially Equivalent | Omay(Guangzhou)Med Technologies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 5, 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.