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Endoscope Camera Head

by Shenzhen Proxinse Medical Technology Co., Ltd.

Model CH-4K，CH-4KZ

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 Number6974626430043BH Basic UDI-DI 06974626430043UDI-DIDate18 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  • Withdrawn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 Camera Head
Model / Reference
CH-4K，CH-4KZ
Primary DI / UDI-DI
06974626430043
Basic UDI-DI
6974626430043BH
EMDN Code
Z12029009 Laparoscopes
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