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Mobile Radiography System

EUDAMED

Class IIb (EU MDR)

Ref MobiEye 810Model MobiEye 700

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Identity

Device Name
Mobile Radiography System EUDAMED
Model / Reference
MobiEye 700 EUDAMED
MobiEye 810 EUDAMED

Identifiers

Primary DI / UDI-DI
06903053081740 EUDAMED
Basic UDI-DI
69449040AB060100015Y EUDAMED
EMDN Code
Z11031102 DIRECT DIGITAL TELERADIOGRAPHS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany 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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Mobile Radiography System by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000014156
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 16a69d4d-671d-4195-ba22-73eb06ed447c 61 fields · synced Jun 17, 2026