Identity
- Trade Name
- RegenKit® Extracell BMC EUDAMEDRegenKit Extracell BMC EUDAMED
- Device Name
- RegenKit® Extracell BMC EUDAMEDRegenKit Extracell BMC EUDAMED
- Model / Reference
- R-EXB/T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640138980121 EUDAMED
- Basic UDI-DI
- 764013898RKEXTRACELLBMCM6 EUDAMEDB-07640138980121 EUDAMED
- EMDN Code
- B019001 PLATELET GEL AND FIBRIN GLUE PRODUCTION BAGS AND KITS EUDAMEDB0199 BLOOD BAGS AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
RegenKit® Extracell BMC by Regen Lab Sa — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 764013898RKEXTRACELLBMCM6 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 764013898RKEXTRACELLBMCM6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Regen Lab SA
- EUDAMED SRN
- CH-MF-000032231
- Authorised Representative
- RegenLab France FR-AR-000011953
Sources (2)
- EUDAMED 349aa4f5-944e-44e8-b275-5989cdbbf4ab 61 fields · synced Jul 16, 2026
- EUDAMED ce294834-0953-4b41-a36b-5d0eda88213a 61 fields · synced May 18, 2026