Identity
- Trade Name
- OSCAR Prime EUDAMEDGenoray FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- OSCAR (OSCAR Prime(Unique Start FD), OSCAR Classic (Unique Class)) EUDAMED
- Model / Reference
- 108 EUDAMEDOSCAR Prime FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809244060106 EUDAMEDFDA UDI
- Basic UDI-DI
- 880924406OSCARKZ EUDAMED
- 510(k) Number
- K181943 FDA UDI
- FDA Product Code
- OWB FDA UDIJAA FDA UDI
- EMDN Code
- Z11039009 FLUOROSCOPY DEVICES EUDAMED
- GMDN Term
- Mobile 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
No
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 Prime by Genoray Co., Ltd. — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 880924406OSCARKZ | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 880924406OSCARKZ | 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 67608959-e5be-4504-be74-0f866a96af73 61 fields · synced May 30, 2026
- FDA UDI 8c142161-acfd-4342-845c-8dccfbfda6dc 33 fields · synced May 30, 2026