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Bbd

by Jiangsu Kanghua Medical Equipment Co., Ltd. EUDAMED

Active European Union

Ref IV-12Model Plastic spike with φ8 blue air-vent, PE protector, large drip chamber(63mm) with φ14.2 filter, precise regulator, large size ABS flow regulator( white cover blue wheel), Y site, luer lock connector with cap, 1.8m DEHP free tube, PE

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06935491701393 Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

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.

Specification

EUDAMED

Device Name
Disposable Infusion Set without Needle
Model / Reference
Plastic spike with φ8 blue air-vent, PE protector, large drip chamber(63mm) with φ14.2 filter, precise regulator, large size ABS flow regulator( white cover blue wheel), Y site, luer lock connector with cap, 1.8m DEHP free tube, PE, IV-12
Primary DI / UDI-DI
06935491701393
Basic UDI-DI
B-06935491701393
EMDN Code
A03010101 Infusion controllers with or w/o air inlet
Device Class
Class I
Market of Registration
Greece

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 (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No