Identity
- Trade Name
- RegenET EUDAMEDFDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- RegenET/CT EUDAMEDRegenET EUDAMED
- Model / Reference
- R-ET-3 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640138981364 EUDAMEDFDA UDI
- Basic UDI-DI
- 764013898REGENETCTT2 EUDAMEDB-07640138981364 EUDAMED
- FDA Product Code
- KJC FDA UDI
- EMDN Code
- B019001 PLATELET GEL AND FIBRIN GLUE PRODUCTION BAGS AND KITS EUDAMEDB06 CELLULAR OR BIOLOGICAL MANIPULATION DEVICES EUDAMED
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 864.2240 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
RegenET by Regen Lab Sa — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 764013898REGENETCTT2 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 764013898REGENETCTT2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Regen Lab SA
- EUDAMED SRN
- CH-MF-000032231
- Authorised Representative
- RegenLab France FR-AR-000011953
Sources (3)
- EUDAMED 1214f245-baec-42b6-9c3f-2add734483f5 61 fields · synced Jun 19, 2026
- EUDAMED efe35297-8be2-418d-a5c9-5a96eac1f152 61 fields · synced May 19, 2026
- FDA UDI dc1ffab2-7d59-4499-afdb-4df1f2aca320 33 fields · synced May 30, 2026