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Pft Set - Bacterial/Viral Spirometer Filter, Mouthpiece and Nose Clip

by Alerkan Ic Ve Dis Ticaret Limited Sirketi EUDAMED

Withdrawn Not intended for the EU market

Ref 9540Model 9502

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number869908977ALERKANDA Basic UDI-DIDate5 May 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Bacterial-Viral Spirometer Filters
Model / Reference
9502, 9540
Primary DI / UDI-DI
08699089770083
Basic UDI-DI
869908977ALERKANDA
EMDN Code
R049001 Pulmonary function test filters
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
TR-MF-000031927

Other devices from Alerkan Ic Ve Dis Ticaret Limited Sirketi

Properties

Show properties
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No