Identity
- Trade Name
- SOFARMA EUDAMED
- Device Name
- CLOTH ROLL EUDAMED
- Model / Reference
- RCT120641 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08017990120641 EUDAMED
- Basic UDI-DI
- 8017990RCYJA EUDAMED
- EMDN Code
- M050101 PLASTERS ON SPOOLS (ROLLS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Sofarma by Eurosirel Spa — 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 | 8017990RCYJA | Class I | Active |
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Manufacturer
- Manufacturer
- Eurosirel Spa
- EUDAMED SRN
- IT-MF-000005982
Sources (1)
- EUDAMED 5656c49f-8c46-4e45-b8eb-5bc8031024bd 61 fields · synced Jun 18, 2026