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uWS-Angio Software
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 88000900Model uWS-Angio BasicModel uWS-Angio
Identity
- Trade Name
- uWS-Angio Software EUDAMEDuWS FDA UDI
- Generic Name
- Angiographic x-ray system application software FDA UDI
- Device Name
- Angiography X-ray Image Processing Software EUDAMEDFDA UDI
- Model / Reference
- uWS-Angio Basic EUDAMEDFDA UDI88000900 EUDAMEDuWS-Angio EUDAMED
- Description
- Angiography X-ray Image Processing Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576834327 EUDAMEDFDA UDI06971576834341 EUDAMED
- Basic UDI-DI
- 697157683432NM EUDAMED697157683434NR EUDAMED
- Direct Marketing DI
- 06971576834327 EUDAMED06971576834341 EUDAMED
- 510(k) Number
- K243632 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11030192 DIGITAL ANGIOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Angiographic x-ray system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
uWS-Angio Software by Shanghai United Imaging Healthcare Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K243632 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K250040 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697157683432NM | 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 (4)
- EUDAMED 640846cc-e551-4308-887d-ac7b86a1cf78 61 fields · synced Oct 6, 2026
- EUDAMED 3c2de320-cfc6-4044-b1ca-555b99b85f52 61 fields · synced May 19, 2026
- FDA UDI 17a93eaa-2dfb-4cae-a848-3114598b1c5e 35 fields · synced May 30, 2026
- FDA 510(k) K243632 1 fields · synced May 18, 2026