Identity
- Trade Name
- Factor II Skin Shade Etruscan Pink , 30ml EUDAMED
- Device Name
- Prosthetic Silicone Materials EUDAMED
- Model / Reference
- FI-SK35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060483013718 EUDAMED
- Basic UDI-DI
- 506048301TF3D9 EUDAMED
- Direct Marketing DI
- 05060483013718 EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Factor II Skin Shade Etruscan Pink , 30ml by Technovent Limited — Class I — 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 | 506048301TF3D9 | Class I | Active |
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Manufacturer
- Manufacturer
- Technovent Limited
- EUDAMED SRN
- GB-MF-000006738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 57cb45f5-6cad-436a-95b5-23b4c43fc7c6 61 fields · synced Jul 21, 2026