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Disposable Uterine Manipulator and Vaginal Delineators

by Hangzhou Kangji Medical Instrument Co. Ltd 3 variants

Ref 301Y.404Model KJ-JGD30S00, KJ-JGD30M00, KJ-JGD30L00, KJ-JGD35S00, KJ-JGD35M00, KJ-JGD35L00, KJ-JGD38S00, KJ-JGD38M00, KJ-JGD38L00, KJ-JGD41S00, KJ-JGD41M00, KJ-JGD41L00, KJ-JGD45S00, KJ-JGD45M00, KJ-JGD45L00, KJ-JGD50S00, KJ-JGD50M00, KJ-JGD50L00,

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 linked in EUDAMED

A group certificate may exist

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 Number69504655301YK4 Basic UDI-DI 06950465510771UDI-DIDate20 Mar 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
KJ-JGD30S00, KJ-JGD30M00, KJ-JGD30L00, KJ-JGD35S00, KJ-JGD35M00, KJ-JGD35L00, KJ-JGD38S00, KJ-JGD38M00, KJ-JGD38L00, KJ-JGD41S00, KJ-JGD41M00, KJ-JGD41L00, KJ-JGD45S00, KJ-JGD45M00, KJ-JGD45L00, KJ-JGD50S00, KJ-JGD50M00, KJ-JGD50L00, 301Y.404
Primary DI / UDI-DI
06950465510771
Basic UDI-DI
69504655301YK4
EMDN Code
U0899 Gynaecological devices - other
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000008708
Authorised representative
Llins Service & Consulting GmbH DE-AR-000009077

Other devices from Hangzhou Kangji Medical Instrument Co. Ltd

See all devices from Hangzhou Kangji Medical Instrument Co. Ltd →

Properties

  • Sterile

Other properties (12)

  • 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