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RegenKit-BCT-2 Plus
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref RK-BCT-2A
by Regen Lab SA
Identity
- Trade Name
- RegenKit-BCT-2 Plus EUDAMEDRegenKit®-BCT-2 Plus FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- RegenKit-BCT-2 Plus EUDAMED
- Model / Reference
- RK-BCT-2A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640138981227 EUDAMED07640138980039 FDA UDI
- Basic UDI-DI
- B-07640138981227 EUDAMED
- FDA Product Code
- ORG FDA UDI
- EMDN Code
- B0501,B0599 EUDAMED
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
RegenKit-BCT-2 Plus by Regen Lab Sa — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640138981227 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Regen Lab SA
- EUDAMED SRN
- CH-MF-000032231
- Authorised Representative
- RegenLab France FR-AR-000011953
Sources (2)
- EUDAMED d97f59e4-d9d2-4c7a-b12e-f92fde7f900c 61 fields · synced Jul 25, 2026
- FDA UDI a65a777a-0fd4-4c06-af0a-7f4585c348bf 33 fields · synced May 26, 2026