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Injectable Dermal Filler
EUDAMEDClass III (EU MDR)
Ref 08800047403657Model DERMALUX Pro SOFT
Identity
- Trade Name
- Injectable Dermal Filler EUDAMED
- Device Name
- Injectable Dermal Filler EUDAMED
- Model / Reference
- DERMALUX Pro SOFT EUDAMED08800047403657 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800047403657 EUDAMED
- Basic UDI-DI
- B-08800047403657 EUDAMED
- EMDN Code
- V901601 PLASTIC SURGERY AND NON-AESTHETIC PURPOSES GENERIC USE INSTRUMENTS AND KITS, SINGLE-USE 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
Injectable Dermal Filler by SCL 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-08800047403657 | Class III | Active |
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Manufacturer
- Manufacturer
- SCL Co., Ltd.
- EUDAMED SRN
- KR-MF-000007839
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 107af68c-20d6-4686-8e6f-b97f7e449979 61 fields · synced Jun 18, 2026