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uWS-Angio Pro Software
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 88000900Model uWS-Angio Pro
Identity
- Trade Name
- uWS-Angio Pro Software EUDAMED
- Device Name
- Angiography X-ray Image Processing Software EUDAMED
- Model / Reference
- uWS-Angio Pro EUDAMED88000900 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576834334 EUDAMED
- Basic UDI-DI
- 697157683433NP EUDAMED
- Direct Marketing DI
- 06971576834334 EUDAMED
- EMDN Code
- Z11030192 DIGITAL ANGIOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
uWS-Angio Pro Software by Shanghai United Imaging Healthcare Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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 | K250045 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697157683433NP | 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 (2)
- EUDAMED bc1b1ef5-c584-42dd-b8cc-f55eb6f19df9 61 fields · synced Oct 7, 2026
- FDA 510(k) K250045 1 fields · synced May 18, 2026