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88000993
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 88000993Model uAngio AVIVA CX
Identity
- Trade Name
- uAngio FDA UDI
- Generic Name
- Stationary angiographic x-ray system, digital FDA UDI
- Device Name
- Angiographic X-ray System FDA UDI
- Model / Reference
- uAngio AVIVA CX EUDAMEDFDA UDI88000993 EUDAMED
- Description
- Angiographic X-ray System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576833498 EUDAMEDFDA UDI
- Basic UDI-DI
- 697157683349NZ EUDAMED
- 510(k) Number
- K243376 FDA UDI
- FDA Product Code
- OWB FDA UDIJAA FDA UDI
- EMDN Code
- Z11030102 STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES EUDAMED
- GMDN Term
- Stationary angiographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 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
Yes
FDA UDI
88000993 by Shanghai United Imaging Healthcare 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 | K243376 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697157683349NZ | Class IIb | 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 d14eb14e-7107-4aa4-9e52-b1cad8423823 61 fields · synced Oct 6, 2026
- FDA UDI 7ef71dd2-9715-4317-91f9-13cfec84df6a 34 fields · synced May 30, 2026
- FDA 510(k) K243376 1 fields · synced May 18, 2026