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Sterile Infusion Sets for Single Use (with Needle)

by Jiangsu Zhiyu Medical Instrument Co., Ltd. EUDAMED

Active European Union

Ref Rule 7 Sub-clause 1 No IndentModel ZY-2

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69515008SYQ002SG Basic UDI-DIDate15 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR 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
Sterile Infusion Sets for Single Use (with Needle)
Model / Reference
ZY-2, Rule 7 Sub-clause 1 No Indent
Primary DI / UDI-DI
06951500879716
Basic UDI-DI
69515008SYQ002SG
EMDN Code
A03010103 Infusion controllers with flow regulator
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000024555
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Jiangsu Zhiyu Medical Instrument Co., Ltd

See all devices from Jiangsu Zhiyu Medical Instrument Co., Ltd →

Properties

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No