Identity
- Trade Name
- OPELAIII Cx EUDAMED
- Device Name
- OPELAIII Cx EUDAMED
- Model / Reference
- CX_P_01EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14589864500602 EUDAMED
- Basic UDI-DI
- 458986450060MD EUDAMED
- Direct Marketing DI
- 14589864500602 EUDAMED
- EMDN Code
- Z12010702 MOBILE SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
OPELAIII Cx by Taiyo Corporation — 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 | 458986450060MD | Class I | Active |
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Manufacturer
- Manufacturer
- Taiyo Corporation
- EUDAMED SRN
- JP-MF-000046015
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 9d2e6159-a703-4e7b-90b0-e404da9cc3dd 61 fields · synced Jul 11, 2026