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Palex

by Shandong Hapool Medical Technology Co. Ltd 4 variants

Ref 2SSASModel 654256-2SSAS

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number069765747631673K Basic UDI-DI 06976574763167UDI-DIDate10 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  • Withdrawn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
654256-2SSAS, 2SSAS
Primary DI / UDI-DI
06976574763167
Basic UDI-DI
069765747631673K
EMDN Code
A03010102 Infusion controllers with filter (also transfusion controllers)
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
  • Implantable
  • Contains Latex
  • Reprocessed
  • Measuring Function

Other properties (8)

  • Reusable: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No