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Q010105 Yes Ti topaze Opal Evo / Ø 1, 6 / L 10, 5
EUDAMEDClass I (EU MDR)
Ref WPI80040Model OPAL EVO
by Apol
Identity
- Trade Name
- Q010105 Yes Ti topaze Opal Evo / Ø 1,6 / L 10,5 EUDAMED
- Device Name
- Tenon opal evo EUDAMED
- Model / Reference
- OPAL EVO EUDAMEDWPI80040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 36653600035894 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
Q010105 Yes Ti topaze Opal Evo / Ø 1, 6 / L 10, 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 (1)
- EUDAMED 75fb30ad-0bf9-45b1-8f6f-b3e6988d68b8 61 fields · synced Jul 8, 2026