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Série Opal Evo Ø 1, 2
EUDAMEDClass IIa (EU MDR)
Ref PI81000Model SERIE OPAL EVORef WPI81040
by Apol
Identity
- Trade Name
- Série Opal Evo Ø 1,2 EUDAMED
- Device Name
- Série de tenons opal evo + alésoir apolsysteme EUDAMED
- Model / Reference
- SERIE OPAL EVO EUDAMEDPI81000 EUDAMEDWPI81040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 36653600004272 EUDAMED36653600034040 EUDAMED
- Basic UDI-DI
- B-36653600004272 EUDAMEDB-36653600034040 EUDAMED
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Série Opal Evo Ø 1, 2 by Apol — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-36653600004272 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Apol
- EUDAMED SRN
- FR-MF-000001707
Sources (2)
- EUDAMED e58d0ab8-6584-4034-9cda-689072974cae 61 fields · synced Jul 18, 2026
- EUDAMED de5fa13f-893e-4026-b210-fa421840c7ea 61 fields · synced May 19, 2026