Identity
- Trade Name
- RegenKit Surgery EUDAMED
- Device Name
- RegenKit Surgery EUDAMED
- Model / Reference
- RK-SRG AZ/TA1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640138980060 EUDAMED
- Basic UDI-DI
- B-07640138980060 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 Surgery 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-07640138980060 | 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 e5bced94-8214-48ea-93a5-3e2f345a442c 61 fields · synced Jun 18, 2026