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Diagnostic X-ray Equipment

by Ningbo Rundeer Control Equipment Co., Ltd. 7 variants

Ref IFU-XR-04Model XR98(W)

Active European Union

CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06974913927034 Basic UDI-DI 06974913927034UDI-DIDate26 Mar 2024RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Diagnostic X-ray Equipment
Model / Reference
XR98(W), IFU-XR-04
Primary DI / UDI-DI
06974913927034
Basic UDI-DI
B-06974913927034
EMDN Code
Z1103040101 Equipment for conventional endoral radiology
Device Class
Class IIb
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000040569
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Ningbo Rundeer Control Equipment Co., Ltd.

See all devices from Ningbo Rundeer Control Equipment Co., Ltd. →

Properties

Other properties (11)

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