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REVOFIL Aquashine BR
EUDAMEDClass III (EU MDR)
Ref N/AModel REVOFIL Aquashine BR
Identity
- Trade Name
- REVOFIL Aquashine BR EUDAMED
- Device Name
- Soft Filler EUDAMED
- Model / Reference
- REVOFIL Aquashine BR EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809171381343 EUDAMED
- Basic UDI-DI
- B-08809171381343 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 BR 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-08809171381343 | 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 9d0d0d88-28ae-477c-a2aa-56085401cbaf 61 fields · synced Jun 19, 2026