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Mobile Digital Radiography X-ray System

EUDAMED

Class IIb (EU MDR)

Ref N/AModel M50-1A, M800-1E, M880, M40-1, M40-1A

by Beijing Wandong Medical Technology Co., Ltd.

Identity

Trade Name
Mobile Digital Radiography X-ray System EUDAMED
Device Name
Mobile Radiographic Unit EUDAMED
Model / Reference
M50-1A, M800-1E, M880, M40-1, M40-1A EUDAMED
N/A EUDAMED

Identifiers

Primary DI / UDI-DI
06938964315219 EUDAMED
Basic UDI-DI
693896431500NN EUDAMED
EMDN Code
Z11039016 MOBILE RADIOGRAPHIC UNITS 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

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

Mobile Digital Radiography X-ray System by Beijing Wandong Medical Technology 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-000014174
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 1cca9399-831f-40c0-96f0-00dbef171111 61 fields · synced Jun 19, 2026
  • EUDAMED 1cca9399-831f-40c0-96f0-00dbef171111-1 61 fields · synced Jun 10, 2026