Skip to content

Digital Radiography System

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 12 variants

Ref DigiEye 330T, DigiEye 350T, DigiEye 680E, DigiEye 680T, DigiEye 680, DigiEye 350, DigiEye 680P, DigiEye 360P, DigiEye 350E, DigiEye U7T, DigiEye U9 Pro, DigiEye U8 Pro, DigiEye U9 Unix, DigiEye U9X, DigiEye U8 Magic, DigiEye U8Model DigiEye 330 / DigiEye 330E / DigiEye 330P / DigiEye 330T / DigiEye 350 / DigiEye 350E / DigiEye 350P / DigiEye 350T / DigiEye 360 / DigiEye 360E / DigiEye 360P / DigiEye 360T, DigiEye 680/ DigiEye 680P/ DigiEye 680T/ DigiEye 680E/ DigiEye 760, DigiEye U9

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69449040AB0601000466 Basic UDI-DI Date26 Oct 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Digital Radiography System
Model / Reference
DigiEye 330 / DigiEye 330E / DigiEye 330P / DigiEye 330T / DigiEye 350 / DigiEye 350E / DigiEye 350P / DigiEye 350T / DigiEye 360 / DigiEye 360E / DigiEye 360P / DigiEye 360T, DigiEye 330T, DigiEye 350T, DigiEye 680/ DigiEye 680P/ DigiEye 680T/ DigiEye 680E/ DigiEye 760, DigiEye 680E, DigiEye 680T, DigiEye 680, DigiEye 350, DigiEye 680P, DigiEye 360P, DigiEye 350E, DigiEye U9, DigiEye U7T, DigiEye U9 Pro, DigiEye U8 Pro, DigiEye U9 Unix, DigiEye U9X, DigiEye U8 Magic, DigiEye U8
Primary DI / UDI-DI
06903053038690, 06903053038713, 06936415973711, 06936415973735, 06936415973704, 06903053038706, 06936415973728, 06903053049702, 06903053038669, 06903053089999, 06903053090018, 06903053090025, 06903053089968, 06903053089982, 06903053090001, 06903053090063, 06903053090049
Basic UDI-DI
69449040AB0601000466, 69449040AB0501003866, 69449040AB050100505U, 69449040AB050100515W
EMDN Code
Z11031101, Z11031102
Device Class
Class IIb
Class I
EU market of registration
Germany

Manufacturer details

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

Related devices

Category: Stationary basic diagnostic x-ray system, digital

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No