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Mobile C-arm X-ray Equipment

by Jiangsu First-Imaging Medical Equipment Co., Ltd. China EUDAMED

Ref Surgio-B71-MCModel Surgio-B71-MC、Surgio-B71-L EMDN Z11039017

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697519957B71TL Basic UDI-DIDate29 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Mobile C-arm X-ray Equipment
Model / Reference
Surgio-B71-MC、Surgio-B71-L, Surgio-B71-MC
Primary DI / UDI-DI
06975199570228
Basic UDI-DI
697519957B71TL
Direct Marketing DI
06975199570228
EMDN Code
Z11039017 Mobile radioscopic units
Device Class
Class IIb
Market of Registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000036747
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Jiangsu First-Imaging Medical Equipment Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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

Sources (1)

  • EUDAMED 86ddb8bf-93ca-45d7-9af2-d8fe06f3dc5a 61 fields · synced 24 Oct 2026