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Bialmed

by Jiangsu Kanghua Medical Equipment Co., Ltd. China EUDAMED

Ref KM002-2.5LModel ZSQ

EMDN A020102010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06935491700600 Basic UDI-DIDate23 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-06935491700600 Basic UDI-DIDate23 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Disposable Syringes Withtout Needle
Disposable Syringes without Needle
Model / Reference
KM002-2.5L, ZSQ
Primary DI / UDI-DI
06935491700600, 06935491788745
Basic UDI-DI
B-06935491700600, 693549172500KH
EMDN Code
A020102010102 Infusion and irrigation syringes, 2-piece luer cone, 2-piece without needle, 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 & 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 (2)

  • EUDAMED 3aadba53-6445-4b97-ac7e-f5614ef621eb 61 fields · synced 23 Oct 2026
  • EUDAMED 06935491788745|693549172500KH 61 fields · synced 9 Oct 2026