FDA Registration
Active
🇨🇳 China
Vaginal PH Rapid Test
Reg #: 3016630443
·
FEI: 3016630443
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
8
Classifications
1
Registration Details
- Registration Name
- Eugene Biotech Co., Ltd.
- Registration Number
- 3016630443
- FEI Number
- 3016630443
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Build 1, Runcai Intelligent Industrial Park, No.1666 XinYang Road, Fengxian District
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- BioMediCore Inc.
- Operator Number
- 10064231
- Address
- 352 Forest View Dr
- City
- South San Francisco
- State
- CA
- Postal Code
- 94080
- Country
- US
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Paper, Obstetric Ph | LNW | Class 1 | Clinical Chemistry | No | 2023-06-02 |
Proprietary Names
Vaginal PH Rapid Test
Establishment Types
Repack or Relabel Medical Device
Reprocess Single-Use Device
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Remanufacture Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Foreign Private Label Distributor