Identity
- Trade Name
- Omni Legend EUDAMEDOmni FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- Omni Legend EUDAMEDOMNI GANTRY ELECTRONICS ASSY, MEA FDA UDIOMNI GANTRY 24-30 INCL. ELECTRONICS ASSY FDA UDIOMNI GANTRY 24-30 INCL. ELECTRONICS ASSY - WSO FDA UDI
- Model / Reference
- Omni Legend EUDAMEDPCM-PET0012 EUDAMEDLegend FDA UDI
- Description
- OMNI GANTRY ELECTRONICS ASSY, MEA FDA UDIOMNI GANTRY 24-30 INCL. ELECTRONICS ASSY FDA UDIOMNI GANTRY 24-30 INCL. ELECTRONICS ASSY - WSO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278792822 EUDAMEDFDA UDI00195278454218 EUDAMEDFDA UDI00195278901439 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00208H6 EUDAMED
- FDA Product Code
- KPS FDA UDIJAK FDA UDI
- EMDN Code
- Z11020301 CT/PET SYSTEMS EUDAMED
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI892.1750 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 UDIFDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Omni Legend by GE Medical Systems, LLC — 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 | 8406821BUG00208H6 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
- EUDAMED SRN
- US-MF-000018315
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (6)
- EUDAMED d1c58a21-b54c-4025-bd53-05d34655241c 61 fields · synced Jul 27, 2026
- FDA UDI 66c5179d-f2fa-44ab-bcf4-c4f5203954f0 34 fields · synced May 30, 2026
- FDA UDI 934cc703-0681-4e63-974b-325ca91ef465 34 fields · synced May 30, 2026
- FDA UDI e889cc59-6b94-4073-9cd2-3702d3144178 34 fields · synced May 30, 2026
- EUDAMED ac5cf905-7559-4b77-8e20-492332d6a9d9 61 fields · synced Jul 9, 2026
- EUDAMED e1385748-4910-49b5-9e3f-f7bd1b03819c 61 fields · synced Jul 27, 2026