Identity
- Trade Name
- OEC One ASD EUDAMEDOEC FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- OEC One ASD EUDAMEDMEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One ASD FDA UDI
- Model / Reference
- OEC One ASD EUDAMEDOne ASD FDA UDI
- Description
- MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One ASD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278685001 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00455HR EUDAMED
- 510(k) Number
- K240828 FDA UDI
- FDA Product Code
- JAA FDA UDIOWB FDA UDIOXO FDA UDI
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS 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
- France 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
Yes
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
OEC One ASD by GE Hualun Medical Systems Co., Ltd — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240828 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00455HR | Class IIb | Active |
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Manufacturer
- Manufacturer
- GE HUALUN MEDICAL SYSTEMS CO. Ltd
- EUDAMED SRN
- CN-MF-000001189
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED 61a47c13-925b-48f5-b5c4-29a0aaf0e408 61 fields · synced Jul 11, 2026
- FDA UDI 498830b2-c14b-4b0f-80ef-1829a5f8fcdf 34 fields · synced May 30, 2026
- FDA 510(k) K240828 1 fields · synced May 18, 2026