Identity
- Trade Name
- ENA WHITE DESENSITIZER EUDAMED
- Device Name
- Ena White desensitizer EUDAMED
- Model / Reference
- COSM05S-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EMICCOSM05S10C EUDAMED
- Basic UDI-DI
- ++EMICFAM1FVH EUDAMED
- Direct Marketing DI
- +EMICCOSM05S10C EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER 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
Ena White Desensitizer by Micerium 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 | ++EMICFAM1FVH | Class I | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-MF-000010187
Sources (1)
- EUDAMED 862a6d6e-b06c-4fc2-bf9e-930379b1b167 61 fields · synced Jun 18, 2026