Identity
- Model / Reference
- uDR 380i Pro EUDAMED88000684 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576833146 EUDAMED
- Basic UDI-DI
- B-06971576833146 EUDAMED
- EMDN Code
- Z11031102 DIRECT DIGITAL TELERADIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
88000684 by Shanghai United Imaging Healthcare Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222339 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K242515 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06971576833146 | 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 (2)
- EUDAMED e692e154-e509-4426-8699-d95d1a4c9184 61 fields · synced Oct 6, 2026
- FDA 510(k) K222339 1 fields · synced May 18, 2026