Identity
- Trade Name
- RegenKit Extracell BMC2 EUDAMED
- Device Name
- RegenKit Extracell BMC2 EUDAMED
- Model / Reference
- R-EXB/T2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640138980763 EUDAMED
- Basic UDI-DI
- B-07640138980763 EUDAMED
- EMDN Code
- B0199 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
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
RegenKit Extracell BMC2 by Regen Lab Sa — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640138980763 | 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 (1)
- EUDAMED 2b74c152-60a1-47f8-8017-0d451032bc40 61 fields · synced Jun 19, 2026