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Bacterial-Viral Spirometer Filter

by Alerkan Ic Ve Dis Ticaret Limited Sirketi Türkiye EUDAMED

Ref 9505, 9508, 9504Model 9502

EMDN R049001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number869908977ALERKANDA Basic UDI-DIDate5 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Bacterial-Viral Spirometer Filter
Bacterial-Viral Spirometer Filter with Mouthpiece
Device Name
Bacterial-Viral Spirometer Filters
Model / Reference
9502, 9505, 9508, 9504
Primary DI / UDI-DI
08699089770076, 08699089770151, 08699089770175
Basic UDI-DI
869908977ALERKANDA
EMDN Code
R049001 Pulmonary function test filters
Device Class
Class IIa
Market of Registration
Slovenia
Spain

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 (3)

  • EUDAMED 440b793f-d158-4a7c-bc33-8def72f7ee94 61 fields · synced 22 Oct 2026
  • EUDAMED 08699089770151|869908977ALERKANDA 61 fields · synced 17 May 2026
  • EUDAMED 08699089770175|869908977ALERKANDA 61 fields · synced 17 May 2026