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Evo 46000
EUDAMEDClass IIa (EU MDR)
Ref EVO 46000Model Dental Instruments Class IIa, Drill
Identity
- Model / Reference
- Dental Instruments Class IIa, Drill EUDAMEDEVO 46000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435567313683 EUDAMED
- Basic UDI-DI
- 084355673FRESACT EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Evo 46000 by Phibo Dental Solutions S.L. — 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 | 084355673FRESACT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Phibo Dental Solutions S.L.
- EUDAMED SRN
- ES-MF-000024464
Sources (1)
- EUDAMED ff2dbffd-c670-49a3-8282-2be6a89b5cad 61 fields · synced Jun 18, 2026