Identity
- Trade Name
- CUTEGEL EUDAMED
- Device Name
- Cross-linked Hyaluronate Acid Dermal Filler EUDAMED
- Model / Reference
- S EUDAMEDCS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809369092464 EUDAMED
- Basic UDI-DI
- B-08809369092464 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
CUTEGEL is a revolutionary cross-linked hyaluronate acid dermal filler developed by BNC KOREA, Inc. for the treatment of facial wrinkles and fine lines. This innovative device boasts unparalleled efficacy and safety features, making it an ideal solution for those seeking to restore youthful appearance.
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-08809369092464 | Class III | Active |
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Manufacturer
- Manufacturer
- BNC KOREA, Inc.
- EUDAMED SRN
- KR-MF-000008321
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 8cf26078-db78-400b-966d-ceca31319bb0 61 fields · synced Jun 27, 2026