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Endoscope Image Processor

by Shenzhen Proxinse Medical Technology Co., Ltd. 2 variants

Model X1-B, X1-BI, X1-BII, X1-BIII, X1-BIV, X1-BV

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6974626430050BE Basic UDI-DI 06974626430050UDI-DIDate17 Jan 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Endoscope Image Processor
Model / Reference
X1-B, X1-BI, X1-BII, X1-BIII, X1-BIV, X1-BV
Primary DI / UDI-DI
06974626430050
Basic UDI-DI
6974626430050BE
EMDN Code
Z12020406 Video processors
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000008916
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Shenzhen Proxinse Medical Technology 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