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Endoscope Camera (FULL HD Endoscope System; 4K Medical Endoscope Camera System)

by Xuzhou AKX Electronic Science and Technology co.，Ltd 79 variants

Ref AKX-9127HModel YKD-9001; YKD-9006; YKD-9007; YKD-9001E; YKD-9021; YKD-9100; YKD-9101; YKD-9102; YKD-9103; YKD-9107; YKD-9103E; YKD-9107E; YKD-9119; YKD-9122; YKD-9124 ;YKD-9132;YKD-9210;YKD-9211 ;YKD-9124H;YKD-9122H;YKD-9132H;YKD-9101H;YKD-9102T; YKD-9103T;YKD-9107T

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 Number697378758SMNK9000SX Basic UDI-DI 06973787580772UDI-DIDate12 Dec 2022RegisteredStatusActive

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  • Withdrawn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 (FULL HD Endoscope System; 4K Medical Endoscope Camera System)
Model / Reference
YKD-9001, YKD-9006, YKD-9007, YKD-9001E, YKD-9021, YKD-9100, YKD-9101, YKD-9102, YKD-9103, YKD-9107, YKD-9103E, YKD-9107E, YKD-9119, YKD-9122, YKD-9124, YKD-9132, YKD-9210, YKD-9211, YKD-9124H, YKD-9122H, YKD-9132H, YKD-9101H, YKD-9102T, YKD-9103T, YKD-9107T, AKX-9127H
Primary DI / UDI-DI
06973787580772
Basic UDI-DI
697378758SMNK9000SX
EMDN Code
Z12020405 Surgical cameras
Models / Variants
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000031488
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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