Identity
- Trade Name
- RegenCT EUDAMED
- Device Name
- RegenCT EUDAMEDRegenET/CT EUDAMED
- Model / Reference
- R-CT-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640138980084 EUDAMED
- Basic UDI-DI
- B-07640138980084 EUDAMED764013898REGENETCTT2 EUDAMED
- EMDN Code
- B06 CELLULAR OR BIOLOGICAL MANIPULATION DEVICES EUDAMEDB019001 PLATELET GEL AND FIBRIN GLUE PRODUCTION BAGS AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMEDFrance 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
RegenCT by Regen Lab Sa — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07640138980084 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07640138980084 | Class IIa | 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 ae91bb43-67a4-4426-bda7-f7c9ac556963 61 fields · synced Jun 19, 2026
- EUDAMED e2efe599-0394-484f-99f7-a0e081821629 61 fields · synced May 19, 2026