Identity
- Trade Name
- Sofiderm EUDAMED
- Device Name
- Cross-linked Sodium Hyaluronate Gel for Plastic Surgery EUDAMED
- Model / Reference
- Derm Plus EUDAMED20ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924616668116 EUDAMED
- Basic UDI-DI
- B-06924616668116 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
Sofiderm by Hangzhou Techderm Biological Products 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-06924616668116 | Class III | Active |
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Manufacturer
- Manufacturer
- Hangzhou Techderm Biological Products Co.Ltd
- EUDAMED SRN
- CN-MF-000009378
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 6b6e8dca-1517-4add-a73b-3a7389fe61c2 61 fields · synced Jun 18, 2026