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Bougie Dilator Set

by Changzhou Jiuhong Medical Instrument Co., Ltd. China EUDAMED

Ref JHK-15 EMDN G03010201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06942000240458 Basic UDI-DIDate18 Apr 2026RegisteredStatusActive
European UnionCE/MDD NumberB-06942000240458 Basic UDI-DIDate18 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Trade Name
Bougie Dilator Set
Bougie Dilators
Model / Reference
JHK-15
Primary DI / UDI-DI
06942000240458, 06942000203064
Basic UDI-DI
B-06942000240458, 69420002050N6
EMDN Code
G03010201, G010102
Device Class
Class I
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000016791
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Changzhou Jiuhong Medical Instrument Co., Ltd.

See all devices from Changzhou Jiuhong Medical Instrument Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (3)

  • EUDAMED d6bbec98-3c5e-44d0-a787-c23b377b9c7a 61 fields · synced 23 Oct 2026
  • EUDAMED 06942000203064|69420002050N6 61 fields · synced 21 Oct 2026
  • EUDAMED 06942000240458|69420002050N6 61 fields · synced 24 Oct 2026