← Back to catalogue
Ti Rouge Opal / Ø 1, 4 / L 11, 5
EUDAMEDClass I (EU MDR)
Ref PI20185Model OPALRef WPI20185
by Apol
Identity
- Trade Name
- Ti Rouge Opal / Ø 1,4 / L 11,5 EUDAMED
- Device Name
- Tenon opal EUDAMED
- Model / Reference
- OPAL EUDAMEDPI20185 EUDAMEDWPI20185 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 36653600000144 EUDAMED36653600036570 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 Rouge Opal / 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.OPALHH | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Apol
- EUDAMED SRN
- FR-MF-000001707
Sources (2)
- EUDAMED 5ba8a5f6-7cba-4a62-87b4-d7fb0ad66b4b 61 fields · synced Jul 18, 2026
- EUDAMED 3754c8e0-d052-48a4-9584-404c4f490991 61 fields · synced May 18, 2026