Identity
- Trade Name
- Monoart® Face Mask Protection 4 EUDAMED
- Device Name
- Monoart® MEDICAL FACE MASK TYPE IIR EUDAMED
- Model / Reference
- 217139 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E30721713924 EUDAMED
- Basic UDI-DI
- ++E307MSKT2R4A EUDAMED
- Secondary DI
- +E3072171392 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
Monoart® Face Mask Protection 4 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 | ++E307MSKT2R4A | Class I | Active |
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Manufacturer
- Manufacturer
- Euronda S.p.a.
- EUDAMED SRN
- IT-MF-000007762
Sources (1)
- EUDAMED a6cb03e1-302b-4169-b83e-c8baea03c4d9 61 fields · synced Jun 19, 2026