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88001296
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 88001296Model uOmnispace.CT
Identity
- Trade Name
- uOmnispace FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Medical Image Post-processing Software FDA UDI
- Model / Reference
- uOmnispace.CT EUDAMEDFDA UDI88001296 EUDAMED
- Description
- Medical Image Post-processing Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576834204 EUDAMEDFDA UDI
- Basic UDI-DI
- 697157683420NE EUDAMED
- FDA Product Code
- QIH FDA UDI
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Poland 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
88001296 by Shanghai United Imaging Healthcare Co., Ltd. — Class IIa — 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 | K233209 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697157683420NE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000008501
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 3b033fb8-e937-4405-a4d5-a5a005f1e87e 61 fields · synced Oct 8, 2026
- FDA UDI 12be3a9f-a136-4e2a-b0cb-8cf17a26dad5 35 fields · synced May 30, 2026
- FDA 510(k) K233209 1 fields · synced May 18, 2026