Identity
- Trade Name
- JUVEGEL EUDAMED
- Device Name
- Cross-linked Hyaluronic Acid Dermal Filler with Polynucleotide EUDAMED
- Model / Reference
- Fine, Classic, Volume EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809369094086 EUDAMED
- Basic UDI-DI
- 880936909BNC004HE EUDAMED
- EMDN Code
- X0303 SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Juvegel by BNC KOREA, Inc. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880936909BNC004HE | Class III | Active |
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Manufacturer
- Manufacturer
- BNC KOREA, Inc.
- EUDAMED SRN
- KR-MF-000008321
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (2)
- EUDAMED ed735180-c2c0-4aa1-9688-77282471bdb6 61 fields · synced Jun 18, 2026
- EUDAMED ed735180-c2c0-4aa1-9688-77282471bdb6-1 61 fields · synced Jun 10, 2026