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Lumifil
EUDAMEDClass III (EU MDR)
Ref C7NModel KISSRef LL3KModel L-KISSRef LL3XModel L-MAXRef LL3LModel L-LITERef C7MModel MAX
Identity
- Trade Name
- LUMIFIL EUDAMEDLUMIFIL with Lidocaine EUDAMED
- Device Name
- Cross-linked Hyaluronate Acid Dermal Filler EUDAMEDCross-linked Hyaluronate Acid Dermal Filler with Lidocaine EUDAMED
- Model / Reference
- KISS EUDAMEDC7N EUDAMEDL-KISS EUDAMEDLL3K EUDAMEDL-MAX EUDAMEDLL3X EUDAMEDL-LITE EUDAMEDLL3L EUDAMEDMAX EUDAMEDC7M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809369092754 EUDAMED08809369093010 EUDAMED08809369093027 EUDAMED08809369093003 EUDAMED08809369092778 EUDAMED
- Basic UDI-DI
- B-08809369092754 EUDAMEDB-08809369093010 EUDAMEDB-08809369093027 EUDAMEDB-08809369093003 EUDAMEDB-08809369092778 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye 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
Lumifil by BNC KOREA, 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-08809369092754 | 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 (5)
- EUDAMED 5a664d55-c82f-463d-9ab7-5c3da2b0b467 61 fields · synced Aug 4, 2026
- EUDAMED fad3ede4-561f-4ea0-8dca-fb0670af8c26 61 fields · synced May 16, 2026
- EUDAMED 81a9ebdc-5844-43be-bf48-f4e819f4eb95 61 fields · synced May 17, 2026
- EUDAMED 11bf776a-3c5b-4e15-abe8-51a9f7a29b00 61 fields · synced May 17, 2026
- EUDAMED 77ffa41a-ca45-4927-9ffa-cf0c2c049270 61 fields · synced May 18, 2026