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Dental Cone Beam Computed Tomography System

EUDAMED

Class IIb (EU MDR)

Ref DENTOM

by Shenzhen Anke High-tech Co., Ltd.

Identity

Device Name: Dental Cone Beam Computed Tomography System EUDAMED
Model / Reference: DENTOM EUDAMED

Identifiers

Primary DI / UDI-DI: 06950743809016 EUDAMED
Basic UDI-DI: B-06950743809016 EUDAMED
EMDN Code: Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED

Classification

Device Class: Class IIb 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

Category: Dental digital imaging sensor, intraoral

Dental Cone Beam Computed Tomography System by Shenzhen Anke High-Tech Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Dental digital imaging sensor, intraoral.

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SCHICK33 — SIRONA DENTAL, INC. · Class II
XIOS XG WIFI — SIRONA DENTAL, INC. · Class II

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer: Shenzhen Anke High-tech Co., Ltd.
EUDAMED SRN: CN-MF-000016473
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

EUDAMED d7aa86e0-64be-4e84-81d7-f4e9bed90a78 61 fields · synced Jul 28, 2026