Identity
- Trade Name
- SoFarma - Paracalli ovali EUDAMED
- Device Name
- PROTECTIVE PLASTER FOR CALLUSES EUDAMED
- Model / Reference
- PCL085070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08017990085070 EUDAMED
- Basic UDI-DI
- 8017990PCLH6 EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER 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
Yes
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 - Paracalli ovali 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 | 8017990PCLH6 | Class I | Active |
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Manufacturer
- Manufacturer
- Eurosirel Spa
- EUDAMED SRN
- IT-MF-000005982
Sources (1)
- EUDAMED 049d992c-e9d8-46a9-86c5-c82473bc99a6 61 fields · synced Jul 16, 2026