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Bialmed

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

Ref KM090X50FModel ZSZ-1~ZSZ-238

EMDN A0101010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-16935491700430 Basic UDI-DIDate25 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-16935491700430 Basic UDI-DIDate25 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
Sterile Hypodermic Needles for Single Use
Model / Reference
KM090X50F, ZSZ-1~ZSZ-238
Primary DI / UDI-DI
16935491700430, 06935491777190
Basic UDI-DI
B-16935491700430, 693549170400JW
EMDN Code
A0101010102 Hypodermic syringe needles, w/o safety systems
Device Class
Class IIa
Market of Registration
Greece
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 62ec51de-fd7a-41bf-956e-6263b3536268 61 fields · synced 23 Oct 2026
  • EUDAMED 06935491777190|693549170400JW 61 fields · synced 14 Oct 2026