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Evo 34000
EUDAMEDClass IIa (EU MDR)
Ref EVO 34000Model Dental Instruments Class IIa, DrillRef EVO 38000
Identity
- Model / Reference
- Dental Instruments Class IIa, Drill EUDAMEDEVO 34000 EUDAMEDEVO 38000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435567313652 EUDAMED08436560958703 EUDAMED
- Basic UDI-DI
- 084355673FRESACT EUDAMED0843656095FRESA6E 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 34000 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 (2)
- EUDAMED c3c9df2f-f529-41b5-8a59-ce6bfd684511 61 fields · synced Jul 23, 2026
- EUDAMED 86f322eb-a05b-40f6-8d45-7968482d8838 61 fields · synced May 18, 2026