Identity
- Trade Name
- Fillharmonie EUDAMED
- Device Name
- Cross-linked Hyaluronate Acid Dermal Filler EUDAMED
- Model / Reference
- Orchestra EUDAMEDC6M2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809369092747 EUDAMED
- Basic UDI-DI
- B-08809369092747 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
Fillharmonie 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-08809369092747 | 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 efe64f76-247c-4f11-93b9-ef8e6507ba4c 61 fields · synced Jun 17, 2026