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Magnetic Resonance (MR) Systems

EUDAMED

Class IIa (EU MDR)

Ref N/AModel i_Open 0.3T, i_Open 0.36T, i_Open 0.4T, i_Open 0.5TModel i_Space 1.5T, i_Space 1.5T Plus, i_Space 1.5T Pro, i_Field 1.5T, i_Field 1.5T Plus, i_Field 1.5T Pro, i_Scope, i_Scope X, i_Scope XTModel i_Vision 1.5T Plus, i_Vision 1.5T, i_Vision 1.5T Pro, i_Vision70 1.5T, i_Vision70 1.5T Plus, i_Vision70 1.5T Pro

by Beijing Wandong Medical Technology Co., Ltd.

Identity

Device Name
Magnetic Resonance (MR) Systems EUDAMED
Model / Reference
i_Open 0.3T, i_Open 0.36T, i_Open 0.4T, i_Open 0.5T EUDAMED
N/A EUDAMED
i_Space 1.5T, i_Space 1.5T Plus, i_Space 1.5T Pro, i_Field 1.5T, i_Field 1.5T Plus, i_Field 1.5T Pro, i_Scope, i_Scope X, i_Scope XT EUDAMED
i_Vision 1.5T Plus, i_Vision 1.5T, i_Vision 1.5T Pro, i_Vision70 1.5T, i_Vision70 1.5T Plus, i_Vision70 1.5T Pro EUDAMED

Identifiers

Primary DI / UDI-DI
06938964321029 EUDAMED
06938964329018 EUDAMED
06938964329087 EUDAMED
06938964329025 EUDAMED
06938964322477 EUDAMED
06938964329032 EUDAMED
06938964329056 EUDAMED
06938964329049 EUDAMED
06938964322460 EUDAMED
06938964322125 EUDAMED
Basic UDI-DI
693896432100N9 EUDAMED
693896432800PC EUDAMED
693896432200NE EUDAMED
EMDN Code
Z11050102 OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T EUDAMED
Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED

Classification

Device Class
Class IIa 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

Magnetic Resonance (MR) Systems by Beijing Wandong Medical Technology Co., Ltd. — Class IIa — 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

Manufacturer
Beijing Wandong Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000014174
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (20)

  • EUDAMED 69a431bd-df0b-4300-98c2-00058a0e01ea 61 fields · synced Jul 31, 2026
  • EUDAMED 69a431bd-df0b-4300-98c2-00058a0e01ea-1 61 fields · synced Jun 10, 2026
  • EUDAMED 6a162fe4-b451-4496-b6cc-a018e735552a-1 61 fields · synced Jul 9, 2026
  • EUDAMED 6a162fe4-b451-4496-b6cc-a018e735552a-2 61 fields · synced Jul 9, 2026
  • EUDAMED f3a8a24f-0dfc-4b3d-84aa-71e46d72d9fa-1 61 fields · synced Jul 11, 2026
  • EUDAMED f3a8a24f-0dfc-4b3d-84aa-71e46d72d9fa-2 61 fields · synced Jul 11, 2026
  • EUDAMED 3e1256c4-6573-42e2-bdac-844c45259500-1 61 fields · synced Jul 11, 2026
  • EUDAMED 3e1256c4-6573-42e2-bdac-844c45259500-2 61 fields · synced Jul 11, 2026
  • EUDAMED 4642531e-37f9-4b25-a3ac-d18373d4932d-1 61 fields · synced Jul 11, 2026
  • EUDAMED 4642531e-37f9-4b25-a3ac-d18373d4932d-2 61 fields · synced Jul 11, 2026
  • EUDAMED 3ca84b0a-c596-4b93-99a8-47373957d0e1-1 61 fields · synced Jul 13, 2026
  • EUDAMED 3ca84b0a-c596-4b93-99a8-47373957d0e1-2 61 fields · synced Jul 13, 2026
  • EUDAMED d44114f2-f483-4eb6-b90d-15fb9e108977-1 61 fields · synced Jul 15, 2026
  • EUDAMED d44114f2-f483-4eb6-b90d-15fb9e108977-2 61 fields · synced Jul 15, 2026
  • EUDAMED 65c72281-6f75-4e2a-8a8f-54d7b1c567fb-1 61 fields · synced Jul 17, 2026
  • EUDAMED 65c72281-6f75-4e2a-8a8f-54d7b1c567fb-2 61 fields · synced Jul 17, 2026
  • EUDAMED b99d695e-66e1-459c-a0a7-18066adf7b69-1 61 fields · synced Jul 26, 2026
  • EUDAMED b99d695e-66e1-459c-a0a7-18066adf7b69-2 61 fields · synced Jul 26, 2026
  • EUDAMED d515a9dc-201f-49ae-9158-00069363d64a-1 61 fields · synced Jul 31, 2026
  • EUDAMED d515a9dc-201f-49ae-9158-00069363d64a-2 61 fields · synced Jul 31, 2026