FDA Registration
Active
🇺🇸 United States
RegenKit - THT
Reg #: 3010512490
·
FEI: 3010512490
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Regenlab USA LLC
- Registration Number
- 3010512490
- FEI Number
- 3010512490
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 95 Greene St
- City
- Jersey City
- State
- NJ
- ZIP
- 07302
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK090048
Owner / Operator
- Firm Name
- RegenLab
- Operator Number
- 10033110
- Address
- 95 Greene St, Jersey City
- City
- Jersey City
- State
- NJ
- Postal Code
- 07302
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2010-07-13 |
Proprietary Names
RegenKit - THT
Establishment Types
Manufacture Medical Device