Identity
- Trade Name
- PRIMOPLAST EUDAMED
- Device Name
- CLOTH ROLL EUDAMED
- Model / Reference
- RCT022481 EUDAMEDRCS016446 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03564700022481 EUDAMED03564706016446 EUDAMED
- Basic UDI-DI
- 8017990RCYJA EUDAMED
- EMDN Code
- M050101 PLASTERS ON SPOOLS (ROLLS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDPoland 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
Primoplast 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 (2)
- EUDAMED 1fd37bc1-211a-4fe7-be4c-647d60d3a941 61 fields · synced Oct 7, 2026
- EUDAMED 2eaafa09-0445-4afd-a10e-3f50dfefa234 61 fields · synced May 18, 2026