FDA Registration
Active
🇰🇪 Kenya
Gauze Swab With X-Ray
Reg #: 3030394731
·
FEI: 3030394731
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- FULLCARE (KENYA) MEDICAL SEZ LIMITED
- Registration Number
- 3030394731
- FEI Number
- 3030394731
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot No.ML-17B within LR No 31327, Tatu City Industrial Park Phase 2 , Ruiru
- City
- Nairobi Nairobi City
- Country
- KE
Owner / Operator
- Firm Name
- FULLCARE (KENYA) MEDICAL SEZ LIMITED
- Operator Number
- 10089791
- Address
- Plot No.ML-17B within LR No 31327, Tatu City Industrial Park Phase 2 , Ruiru
- City
- Nairobi
- State
- Nairobi City
- Postal Code
- 00100
- Country
- KE
- Correspondent
- Frederic Cao
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln. Dover, Delaware, 19901, UNITED STATES
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2025-05-14 |
Proprietary Names
Gauze Swab With X-Ray
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)