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Cross-linked Hyaluronic Acid with Lidocaine and Polynucleotide
EUDAMEDClass III (EU MDR)
Ref PNfill Light
Identity
- Device Name
- Cross-linked Hyaluronic Acid with Lidocaine and Polynucleotide EUDAMED
- Model / Reference
- PNfill Light EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800065900220 EUDAMED
- Basic UDI-DI
- B-08800065900220 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
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
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Cross-linked Hyaluronic Acid with Lidocaine and Polynucleotide by BMI Korea 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-08800065900220 | Class III | Active |
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Manufacturer
- Manufacturer
- BMI Korea Co., Ltd.
- EUDAMED SRN
- KR-MF-000035107
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 7a1d85c7-4d0a-433d-ba4d-23b8b81f900c 61 fields · synced Jun 19, 2026