Skip to content

Endoscopic Imaging System

by Nanjing Tuge Healthcare Co., Ltd. 46 variants

Ref AIENDO-4Ki

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6974439670100E2 Basic UDI-DI 06974439670155UDI-DIDate22 May 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
AIENDO-4Ki
Primary DI / UDI-DI
06974439670155
Basic UDI-DI
6974439670100E2
Direct Marketing DI
06974439670155
EMDN Code
Z12020405 Surgical cameras
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000018925
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Nanjing Tuge Healthcare Co., Ltd.

See all devices from Nanjing Tuge Healthcare 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