Identity
- Trade Name
- Surgical Face Masks EUDAMED
- Device Name
- Monoart® MEDICAL FACE MASK TYPE II EUDAMED
- Model / Reference
- 217179 EUDAMED217176 EUDAMED217178 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E3072171791 EUDAMED+E3072171761 EUDAMED+E3072171781 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 (3)
- EUDAMED 3188151a-62a5-4d44-bb2a-05d791b380c5 61 fields · synced Oct 6, 2026
- EUDAMED 37747b46-5fad-4a6b-ad2c-c29998cf2223 61 fields · synced May 19, 2026
- EUDAMED fa6e4b2d-5624-4d25-9515-bcea5a0a9435 61 fields · synced May 19, 2026