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X-ray computed Tomography System

EUDAMED

Class IIb (EU MDR)

Ref ANATOM Precision

by Shenzhen Anke High-tech Co., Ltd.

Identity

Device Name
X-ray computed Tomography System EUDAMED
Model / Reference
ANATOM Precision EUDAMED

Identifiers

Primary DI / UDI-DI
06950743802086 EUDAMED
Basic UDI-DI
B-06950743802086 EUDAMED
EMDN Code
Z11030605 COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Italy 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

X-ray computed Tomography System by Shenzhen Anke High-Tech Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
CN-MF-000016473
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 797e56f5-9418-488a-9191-00807ddc953a 61 fields · synced Jun 19, 2026