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Disposable Infusion Sets

by Shandong Kanglilai Medical Apparatus Co., Ltd. 2 variants

Ref IV-6-5, IV-6-5 Y, IV-6-5YModel IV-6-5Y、IV-6-1Y、IV-6-5

Active European Union

CE MDR

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 Number69489152IV005TH Basic UDI-DI Date10 Mar 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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
IV-6-5Y、IV-6-1Y、IV-6-5, IV-6-5, IV-6-5 Y, IV-6-5Y
Primary DI / UDI-DI
06948915201164, 06948915201195, 06948915201188, 06948915201201, 06948915200105
Basic UDI-DI
69489152IV005TH
EMDN Code
A03010101 Infusion controllers with or w/o air inlet
Device Class
Class IIa
EU market of registration
Italy
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000039434
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shandong Kanglilai Medical Apparatus Co., Ltd.

Properties

  • Sterile
  • Contains Latex NoEUDAMEDYesEUDAMED
  • Administering Medicine

Other properties (10)

  • Implantable: No
  • Reusable: 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