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Bialmed

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

Ref KM005LW, PSM4100-50BModel ZSQ, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06935491700082 Basic UDI-DI Date23 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-06935491700082 Basic UDI-DI Date23 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  • Withdrawn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
Model / Reference
KM005LW, ZSQ, ZSQ without needle, PSM4100-50B
Primary DI / UDI-DI
06935491700082, 06935491788660
Basic UDI-DI
B-06935491700082, 693549172500KH, 693549171500KA
EMDN Code
A020102010102, A020102020102
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