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Autologous Cellper Kit
EUDAMEDClass IIa (EU MDR)
Ref A-BMC-15QRef Acti-PRP-15DRef Acti-PRP-10G
Identity
- Trade Name
- Autologous Cellper Kit EUDAMED
- Device Name
- Autologous Cellper Kit EUDAMED
- Model / Reference
- A-BMC-15Q EUDAMEDActi-PRP-15D EUDAMEDActi-PRP-10G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875911040 EUDAMED04719875911057 EUDAMED04719875911026 EUDAMED
- Basic UDI-DI
- B-04719875911040 EUDAMEDB-04719875911057 EUDAMEDB-04719875911026 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 Cellper 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-04719875911040 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aeon Biotherapeutics Corp.
- EUDAMED SRN
- TW-MF-000014695
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 93d3c75b-63b9-44ea-b7b5-622a89bf59c2 61 fields · synced Jul 27, 2026
- EUDAMED 254e1842-885d-4f10-a304-be1e7c81c421 61 fields · synced May 17, 2026
- EUDAMED 530972ea-f9ff-4260-a545-b6f230a97d05 61 fields · synced May 17, 2026