Identity
- Trade Name
- MONOART® EM21 EUDAMED
- Model / Reference
- MONOART® EM21 EUDAMED229XXXXX EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-EM21HX EUDAMED
- Basic UDI-DI
- B-EM21HX EUDAMED
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Monoart® Em21 by Euronda S.p.a. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-EM21HX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Euronda S.p.a.
- EUDAMED SRN
- IT-MF-000007762
Sources (1)
- EUDAMED 0e2f61b8-e682-448d-a068-24d6fcd16249 61 fields · synced Jun 18, 2026