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Cross-linked Hyaluronic Acid with Lidocaine and Polynucleotide
EUDAMEDClass III (EU MDR)
Ref Renefil® Deep PlusRef REJUfeel Light PlusRef Renefil® Ultra PlusRef Renefil® Light PlusRef Prodermis PROSCULPT DeepRef REJUfeel Deep Plus
Identity
- Device Name
- Cross-linked Hyaluronic Acid with Lidocaine and Polynucleotide EUDAMED
- Model / Reference
- Renefil® Deep Plus EUDAMEDREJUfeel Light Plus EUDAMEDRenefil® Ultra Plus EUDAMEDRenefil® Light Plus EUDAMEDProdermis PROSCULPT Deep EUDAMEDREJUfeel Deep Plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800065900206 EUDAMED08800065910168 EUDAMED08800065900183 EUDAMED08800065900190 EUDAMED08800065900268 EUDAMED08800065910175 EUDAMED
- Basic UDI-DI
- B-08800065900206 EUDAMEDB-08800065910168 EUDAMEDB-08800065900183 EUDAMEDB-08800065900190 EUDAMEDB-08800065900268 EUDAMEDB-08800065910175 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
- Cyprus 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-08800065900206 | 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 (6)
- EUDAMED 7da49eba-6467-4dc1-ac78-deee57ea9c5a 61 fields · synced Oct 6, 2026
- EUDAMED 6a17622a-60fe-497f-a4d6-5a2c6e80336c 61 fields · synced May 17, 2026
- EUDAMED e9e6d3ae-6459-4e43-89a3-2b04a1f5deaa 61 fields · synced May 17, 2026
- EUDAMED d3c1c394-df9c-4166-9729-27ae937e1a50 61 fields · synced May 18, 2026
- EUDAMED 49b18550-0251-4f77-8806-01f7963713c3 61 fields · synced May 18, 2026
- EUDAMED d9f8a93d-8c3d-4c75-bc87-2c347046063a 61 fields · synced May 19, 2026