← Back to catalogue
Autologous CellPrep Kit
EUDAMEDClass IIa (EU MDR)
Ref Acti-PRP-15Model Acti-PRP-15G
Identity
- Trade Name
- Autologous CellPrep Kit EUDAMED
- Device Name
- Autologous CellPrep Kit EUDAMEDAutologous Cellper Kit EUDAMED
- Model / Reference
- Acti-PRP-15 EUDAMEDActi-PRP-15G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875911002 EUDAMED04719875911019 EUDAMED
- Basic UDI-DI
- B-04719875911002 EUDAMEDB-04719875911019 EUDAMED
- EMDN Code
- B0501,B0599 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Autologous CellPrep Kit by Aeon Biotherapeutics Corp. — Class IIa — 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-04719875911002 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aeon Biotherapeutics Corp.
- EUDAMED SRN
- TW-MF-000014695
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 4c555b5c-5848-42cc-a6db-ee660fd7b584 61 fields · synced Jul 27, 2026
- EUDAMED 49f333ef-20c5-4be2-8a1b-124e343d9be1 61 fields · synced May 19, 2026