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Pft Set - Bacterial/Viral Spirometer Filter with Mouthpiece

by Alerkan Ic Ve Dis Ticaret Limited Sirketi Türkiye EUDAMED

Ref 9530Model 9502 EMDN R049001

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  • Withdrawn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European Union — CE/MDR Withdrawn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 · synced 24 Oct 2026

Device Name
Bacterial-Viral Spirometer Filters
Model / Reference
9502, 9530
Primary DI / UDI-DI
08699089770205
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 & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED aa497d6c-3597-4934-acb7-ca604d04517f 61 fields · synced 24 Oct 2026