Identity
- Trade Name
- AestheFill-V200 EUDAMED
- Device Name
- AestheFill EUDAMED
- Model / Reference
- AestheFill-V200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800050800115 EUDAMED
- Basic UDI-DI
- B-08800050800115 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
AestheFill-V200 by Regen Biotech Inc. — Class III — 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-08800050800115 | Class III | Active |
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Manufacturer
- Manufacturer
- Regen Biotech Inc.
- EUDAMED SRN
- KR-MF-000030567
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 2ec36bfc-1171-453c-bb79-77b33cc500ff 61 fields · synced Jun 18, 2026