Omay(Guangzhou) MED Technologies Co., Ltd.
Manufacturer and brand owner in Guangzhou, Guangdong, China. 1 device type, 1 product catalogued, 1 clearance.
Omay(Guangzhou) MED Technologies Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Device, Counter-Pulsating, External. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
1device type
1product
1510(k) clearance
Registration
| Registered name | OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3028606342 |
| FEI number | 3028606342 |
| DUNS | 547000751 |
| Establishment type | Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 广州奥迈医疗科技有限公司 |
|---|---|
| Unified social credit code | 91440106671815737L |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | Room 501 and Room 302,No.600-1,Guangshan 2nd Road,Fenghuang Streat,Tianhe Dist. |
| Postal code | 510000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Device, Counter-Pulsating, External | Class 2 | NovaHeart | 2023 | 3 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Omay | DRN | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K191955 | 2020-08-05 | DRN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Employees | 20 R&D team members (total workforce not disclosed) |
| Factory area | 1600 (unit not specified on website) |
| Main products | Enhanced External Counterpulsation (EECP) machines, Rehabilitation medical devices, Shock wave therapy devices, External sequential compression devices, Electrotherapy equipment |
| Certifications | CE, ISO13485, CFDA, CFS, CB |
| Export markets | Malaysia, India, Indonesia, Pakistan, Australia, Kuwait, France, Spain, UK, Europe, America, Middle East, Southeast Asia |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.