Identity
- Trade Name
- OSCAR 15iL EUDAMED
- Device Name
- OSCAR 15FD (Unique FD, OPESCOPE ACTENO FD15, SC15), OSCAR 15i, OSCAR 15iL EUDAMED
- Model / Reference
- A01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809244060519 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
OSCAR 15iL 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 (1)
- EUDAMED 09bbbdb3-f21e-4fc8-a57d-87dc3e8be88c 61 fields · synced Jul 12, 2026