FDA Registration
Active
🇺🇸 United States
Regenlab USA LLC
Reg #: 3010512490
·
FEI: 3010512490
·
Expires 2026
Products
8
Proprietary Names
9
Establishment Types
4
Classifications
8
Registration Details
- Registration Name
- Regenlab USA LLC
- Registration Number
- 3010512490
- FEI Number
- 3010512490
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 95 Greene St
- City
- Jersey City
- State
- NJ
- ZIP
- 07302
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK120057
Owner / Operator
- Firm Name
- RegenLab
- Operator Number
- 10033110
- Address
- 95 Greene St
- City
- Jersey City
- State
- NJ
- Postal Code
- 07302
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2024-08-23 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2014-04-11 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2022-11-29 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2022-11-29 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2010-07-13 |
| Bottle, Roller, Tissue Culture | KJC | Class 1 | Hematology | No | 2015-06-30 |
| Peripheral Blood Processing Device For Wound Management | PMQ | Class 2 | Hematology | No | 2023-02-24 |
| Media And Components, Synthetic Cell And Tissue Culture | KIT | Class 1 | Hematology | No | 2021-06-23 |
Proprietary Names
A-CP-Kit Family Kits
RegenKit-BCT-1 Plus
RegenKit-BCT-2 Plus
RegenKit - THT
RegenET (ref: R-ET-3, R-ET-3 x 10)
RegenBMC
RegenKit-BCT Family Kits:
RegenKit®-Wound Gel-2
CuteCell in vitro
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)