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Ti saphir Opal Evo / Ø 1, 4 / L 9, 5
EUDAMEDClass I (EU MDR)
Ref WPI80025Model OPAL EVORef PI80025
by Apol
Identity
- Trade Name
- Ti saphir Opal Evo / Ø 1,4 / L 9,5 EUDAMED
- Device Name
- Tenon opal evo EUDAMED
- Model / Reference
- OPAL EVO EUDAMEDWPI80025 EUDAMEDPI80025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 36653600035344 EUDAMED36653600002292 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 9, 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 1a824a60-f854-45a9-a5c8-99b924a4fa6f 61 fields · synced Jul 17, 2026
- EUDAMED 32e4a248-571f-4c09-84d9-8f9691b6f7fc 61 fields · synced May 18, 2026