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Monoart® EM21
EUDAMEDClass IIa (EU MDR)
Ref 22931001Model EM21Ref 22931009Ref 22931003Ref 22931007Ref 22931008Ref 22931005
Identity
- Trade Name
- Monoart® EM21 EUDAMED
- Model / Reference
- EM21 EUDAMED22931001 EUDAMED22931009 EUDAMED22931003 EUDAMED22931007 EUDAMED22931008 EUDAMED22931005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E307229310011+ EUDAMED+E3072293100927 EUDAMED+E3072293100321 EUDAMED+E3072293100725 EUDAMED+E3072293100826 EUDAMED+E3072293100523 EUDAMED
- Basic UDI-DI
- ++E307EM217D EUDAMED
- Secondary DI
- +E307229310011 EUDAMED+E307229310091 EUDAMED+E307229310031 EUDAMED+E307229310071 EUDAMED+E307229310081 EUDAMED+E307229310051 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
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® EM21 by Euronda S.p.a. — Class IIa — 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 | ++E307EM217D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Euronda S.p.a.
- EUDAMED SRN
- IT-MF-000007762
Sources (6)
- EUDAMED e075eecc-b538-4fa3-92a7-c6f597841f01 61 fields · synced Sep 30, 2026
- EUDAMED 45e1a122-1e77-4d9e-b5fb-a90bf54898bd 61 fields · synced May 17, 2026
- EUDAMED e17406ab-8ff2-4810-844f-561a58645fbe 61 fields · synced May 17, 2026
- EUDAMED cc4b0136-ff73-4f9d-992f-d21d35912a16 61 fields · synced May 18, 2026
- EUDAMED eb2722a0-6abf-439e-a769-299168439fcf 61 fields · synced May 19, 2026
- EUDAMED ea46e878-f415-497e-95c6-6be8ec18a849 61 fields · synced May 19, 2026