Identity
- Trade Name
- REVOFIL Ultra EUDAMED
- Device Name
- Deep Touch Filler EUDAMED
- Model / Reference
- REVOFIL Ultra EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809171381374 EUDAMED08809171383965 EUDAMED
- Basic UDI-DI
- B-08809171381374 EUDAMEDB-08809171383965 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 Ultra 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-08809171381374 | 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 (2)
- EUDAMED f9df971c-e3f1-4221-993f-9308a6273405 61 fields · synced Jul 31, 2026
- EUDAMED 12b41210-6280-440c-a1cd-ef9ce72d0065 61 fields · synced May 17, 2026