Identity
- Trade Name
- Surgical Face Masks EUDAMED
- Device Name
- Monoart® MEDICAL FACE MASK TYPE II EUDAMED
- Model / Reference
- 217177 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E3072171771 EUDAMED
- Basic UDI-DI
- ++E307MSKT25G EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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
Surgical Face Masks by Euronda S.p.a. — 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 | ++E307MSKT25G | Class I | Active |
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Manufacturer
- Manufacturer
- Euronda S.p.a.
- EUDAMED SRN
- IT-MF-000007762
Sources (1)
- EUDAMED f48152d6-1244-49a5-babe-841137e659ed 61 fields · synced Jun 19, 2026