Identity
- Trade Name
- OPESCOPE ACTENO FD15 EUDAMED
- Device Name
- OSCAR 15FD (Unique FD, OPESCOPE ACTENO FD15, SC15), OSCAR 15i, OSCAR 15iL EUDAMED
- Model / Reference
- A02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809244060694 EUDAMED08809244060687 EUDAMED
- Basic UDI-DI
- 880924406OSCAR15UD EUDAMED
- EMDN Code
- Z11039009 FLUOROSCOPY DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Opescope Acteno Fd15 by Genoray Co., Ltd. — Class IIb — 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 | 880924406OSCAR15UD | Class IIb | Active |
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Manufacturer
- Manufacturer
- GENORAY CO., Ltd.
- EUDAMED SRN
- KR-MF-000021014
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED f6286db7-0ed0-44a9-b86c-e4bf96727596 61 fields · synced Jul 11, 2026
- EUDAMED a54c1cbf-fb95-4251-a0dd-6dd0f8a54516 61 fields · synced May 19, 2026