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Bialmed

by Jiangsu Kanghua Medical Equipment Co., Ltd. EUDAMED

Active European Union

Ref KM100L-2SModel 100ml catheter, CXQ

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-16935491700751 Basic UDI-DIDate25 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-16935491700751 Basic UDI-DIDate25 May 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  • Withdrawn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

Device Name
Disposable Catheter Tip Syringes
Model / Reference
100ml catheter, KM100L-2S, CXQ
Primary DI / UDI-DI
16935491700751, 06935491777084
Basic UDI-DI
B-16935491700751, 693549171200JT
EMDN Code
A02010203 Infusion and irrigation syringes, catheter cone, single-use
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000033842
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jiangsu Kanghua Medical Equipment Co., Ltd.

See all devices from Jiangsu Kanghua Medical Equipment 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