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Ti saphir Opal Evo / Ø 1, 4 / L 8, 5
EUDAMEDClass I (EU MDR)
Ref WPI80020Model OPAL EVORef PI80020
by Apol
Identity
- Trade Name
- Ti saphir Opal Evo / Ø 1,4 / L 8,5 EUDAMED
- Device Name
- Tenon opal evo EUDAMED
- Model / Reference
- OPAL EVO EUDAMEDWPI80020 EUDAMEDPI80020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 36653600035276 EUDAMED36653600002360 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 8, 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 37636fef-f920-4c2c-81b4-506f5a84483e 61 fields · synced Jul 26, 2026
- EUDAMED 71b74c1f-bc5a-49b7-a83c-32753b099f49 61 fields · synced May 18, 2026