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88000845

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 88000845Model uWS-MI

by Shanghai United Imaging Healthcare Co., Ltd.

Identity

Model / Reference
uWS-MI EUDAMED
88000845 EUDAMED

Identifiers

Primary DI / UDI-DI
D-CN-MF-000008501S4 EUDAMED
06971576834068 EUDAMED
Basic UDI-DI
B-CN-MF-000008501S4 EUDAMED
697157683406NL EUDAMED
EMDN Code
Z11020392 INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Special Device Type
-1192 EUDAMED
Software EUDAMED
Market of Registration
Italy EUDAMED
Romania 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

88000845 by Shanghai United Imaging Healthcare Co., Ltd. — Class IIa — FDA_510K, MDR, 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/MDR

European Union Active

CE/MDD

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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 bbb21bcc-5365-4194-8bcb-2f8a3e635c7d 61 fields · synced Oct 9, 2026
  • EUDAMED 6257f742-eebe-43b4-a40f-d6c54929985f 61 fields · synced May 17, 2026
  • FDA 510(k) K172998 1 fields · synced May 18, 2026