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Ti saphir Opal Evo / Ø 1, 4 / L 11, 5
EUDAMEDClass I (EU MDR)
Ref PI80032Model OPAL EVORef WPI80032
by Apol
Identity
- Trade Name
- Ti saphir Opal Evo / Ø 1,4 / L 11,5 EUDAMED
- Device Name
- Tenon opal evo EUDAMED
- Model / Reference
- OPAL EVO EUDAMEDPI80032 EUDAMEDWPI80032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 36653600002056 EUDAMED36653600035580 EUDAMED
- Basic UDI-DI
- 3665360TEMP.OPALEVON9 EUDAMED
- EMDN Code
- Q010105 RECONSTRUCTION ENDODONTIC PINS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Ti saphir Opal Evo / Ø 1, 4 / L 11, 5 by Apol — 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 | 3665360TEMP.OPALEVON9 | Class I | Active |
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Manufacturer
- Manufacturer
- Apol
- EUDAMED SRN
- FR-MF-000001707
Sources (2)
- EUDAMED 78e1ae6c-6a9d-46c0-9e63-11868f5a3d14 61 fields · synced Aug 1, 2026
- EUDAMED 0596f513-37c9-4a1d-97c5-de0da8c7fbde 61 fields · synced May 16, 2026