FDA Registration
Active
🇨🇳 China
OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD
Reg #: 3028606342
·
FEI: 3028606342
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD
- Registration Number
- 3028606342
- FEI Number
- 3028606342
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 501 and Room 302,No.600-1,Guangshan 2nd Road,Fenghuang Streat,Tianhe Dist.
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K191955
Owner / Operator
- Firm Name
- Omay(Guangzhou) Med Technologies Co., Ltd
- Operator Number
- 10089276
- Address
- Room 501 and Room 302,No.600-1,Guangshan 2nd Road,Fenghuang Streat,Tianhe Dist.
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510000
- Country
- CN
- Correspondent
- Jane Liao
US Agent
- Business Name
- NovaHeart
- Contact Name
- Paola Morales-Carvajal
- Address
- 110 Calle Del Parque
- City
- San Juan
- State
- PR
- ZIP
- 00911
- Country
- US
- [email protected]
- Phone
- 787 4243262
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Counter-Pulsating, External | DRN | Class 2 | Cardiovascular | No | 2023-11-22 |
Proprietary Names
NovaHeart
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Foreign Private Label Distributor