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Palex

by Shandong Hapool Medical Technology Co. Ltd 4 variants

Ref KRFCVModel krfcv

Active European Union

CE MDR CE MDD

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 NumberB-06976574761293 Basic UDI-DI Date22 Jul 2026RegisteredStatusActive
European UnionCE/MDD NumberB-06976574761293 Basic UDI-DI Date22 Jul 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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Disposable Infusion set Auto airstop liquid
Disposable Sterile, Infusion Set - Auto Airstop Liquid
Infusion Set Auto Air-Stop
Model / Reference
KRFCV
Primary DI / UDI-DI
06976574761293, 06976574764027
Basic UDI-DI
B-06976574761293, 6976574764027KRFCVVL, 06976574764KRFCVGR
Direct Marketing DI
06976574761293
EMDN Code
A03010101 Infusion controllers with or w/o air inlet
Device Class
Class IIa
EU market of registration
Spain

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
  • Contains Latex
  • Reprocessed YesEUDAMEDNoEUDAMED
  • Administering Medicine YesEUDAMEDNoEUDAMED

Other properties (9)

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