← Back to catalogue
RegenKit Extracell Membrane
EUDAMEDClass IIb (EU MDR)
Ref R-EXM/T
by Regen Lab SA
Identity
- Trade Name
- RegenKit Extracell Membrane EUDAMED
- Device Name
- RegenKit Extracell Membrane EUDAMED
- Model / Reference
- R-EXM/T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640138980725 EUDAMED
- Basic UDI-DI
- B-07640138980725 EUDAMED
- EMDN Code
- B0501,B0599 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 Membrane 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-07640138980725 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Regen Lab SA
- EUDAMED SRN
- CH-MF-000032231
- Authorised Representative
- RegenLab France FR-AR-000011953
Sources (1)
- EUDAMED c4003a99-3bc4-4028-9c4a-072c3218f12a 61 fields · synced Jul 31, 2026