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Ti Or Opal / Ø 1, 4 / L 9, 5
EUDAMEDClass I (EU MDR)
Ref WPI20165Model OPALRef PI20165
by Apol
Identity
- Trade Name
- Ti Or Opal / Ø 1,4 / L 9,5 EUDAMED
- Device Name
- Tenon opal EUDAMED
- Model / Reference
- OPAL EUDAMEDWPI20165 EUDAMEDPI20165 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 36653600036334 EUDAMED36653600000458 EUDAMED
- Basic UDI-DI
- 3665360TEMP.OPALHH 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 Or Opal / 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.OPALHH | Class I | Active |
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Manufacturer
- Manufacturer
- Apol
- EUDAMED SRN
- FR-MF-000001707
Sources (2)
- EUDAMED 979a854a-5e9d-4e62-822b-58bd41c20b2c 61 fields · synced Jul 19, 2026
- EUDAMED f8039bd8-faf1-4066-8205-8045950561b9 61 fields · synced May 18, 2026