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Silicone Scar Roll
EUDAMEDClass I (EU MDR)
Ref MG-SKN-SSR01Model Silicone Scar Roll
by Fbgc Limited
Identity
- Device Name
- Silicone Scar Roll EUDAMED
- Model / Reference
- Silicone Scar Roll EUDAMEDMG-SKN-SSR01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060551222004 EUDAMED
- Basic UDI-DI
- 50605512220251014SSR5L EUDAMED
- EMDN Code
- M04010203 FIXATION SILICONE DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Silicone Scar Roll by Fbgc 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 | 50605512220251014SSR5L | Class I | Active |
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Manufacturer
- Manufacturer
- Fbgc Limited
- EUDAMED SRN
- UK-MF-000046785
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED a2099837-3e9c-4869-915f-02f4dd646bdd 61 fields · synced Jun 18, 2026