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Vandl

by Shandong Hapool Medical Technology Co. Ltd

Ref IVB03A

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6976574769671KT Basic UDI-DI 06976574769671UDI-DIDate2 Sep 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  • Withdrawn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

Device Name
Disposable Infusion Set
Model / Reference
IVB03A
Primary DI / UDI-DI
06976574769671
Basic UDI-DI
6976574769671KT
EMDN Code
A03010101 Infusion controllers with or w/o air inlet
Device Class
Class IIa
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000037479
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shandong Hapool Medical Technology Co. Ltd

Properties

  • Sterile
  • Implantable
  • Administering Medicine
  • Measuring Function

Other properties (9)

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