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REVOFIL Aquashine Platinum
EUDAMEDClass III (EU MDR)
Ref N/AModel REVOFIL Aquashine Platinum
Identity
- Trade Name
- REVOFIL Aquashine Platinum EUDAMED
- Device Name
- Soft Filler EUDAMED
- Model / Reference
- REVOFIL Aquashine Platinum EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809171389936 EUDAMED
- Basic UDI-DI
- B-08809171389936 EUDAMED
- EMDN Code
- Y062703 AESTHETIC FILLERS, CALF AND THIGH EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Denmark 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
REVOFIL Aquashine Platinum by Caregen Co., Ltd. — 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-08809171389936 | Class III | Active |
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Manufacturer
- Manufacturer
- Caregen Co., Ltd.
- EUDAMED SRN
- KR-MF-000009948
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 9723a74a-7f1e-4c19-aad6-63b37220f6c1 61 fields · synced Jul 20, 2026