Identity
- Trade Name
- Unique Start FD EUDAMED
- Device Name
- OSCAR (OSCAR Prime(Unique Start FD), OSCAR Classic (Unique Class)) EUDAMED
- Model / Reference
- 108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809244060540 EUDAMED
- Basic UDI-DI
- 880924406OSCARKZ 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Unique Start FD 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 | 880924406OSCARKZ | 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 ad86b641-7be1-4da0-8ae0-556ad786ff38 61 fields · synced Jun 20, 2026