Identity
- Trade Name
- OSCAR 15i EUDAMEDGenoray FDA UDI
- Generic Name
- Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- OSCAR 15FD (Unique FD, OPESCOPE ACTENO FD15, SC15), OSCAR 15i, OSCAR 15iL EUDAMED
- Model / Reference
- A01 EUDAMEDOSCAR 15i FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809244060069 EUDAMEDFDA UDI
- Basic UDI-DI
- 880924406OSCAR15UD EUDAMED
- 510(k) Number
- K230787 FDA UDI
- FDA Product Code
- JAA FDA UDIOWB FDA UDI
- EMDN Code
- Z11039009 FLUOROSCOPY DEVICES EUDAMED
- GMDN Term
- Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
OSCAR 15i by Genoray Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880924406OSCAR15UD | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 e6dda6aa-5e80-43a4-9d4c-0d674520787d 61 fields · synced Jul 18, 2026
- FDA UDI ec079163-cb76-489c-bb68-bb0505d26935 33 fields · synced May 30, 2026