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Bialmed

by Jiangsu Kanghua Medical Equipment Co., Ltd. 57 variants

Ref KM002-2.5LLModel 2(2.5)ml luer lock, ZSQ without needle

Active European Union

CE MDR CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-16935491700713 Basic UDI-DI Date27 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-16935491700713 Basic UDI-DI Date27 May 2026RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Disposable syringes without needle
Disposable Syringes Withtout Needle
Model / Reference
KM002-2.5LL, 2(2.5)ml luer lock, ZSQ without needle
Primary DI / UDI-DI
16935491700713, 26935491700710, 06935491788950
Basic UDI-DI
B-16935491700713, B-26935491700710, 693549171500KA
EMDN Code
A020102020102 Infusion and irrigation syringes, luer lock cone, 3-piece without needle, single-use
Device Class
Class I
EU 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