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Kit Airtest 8T Sibo Lactitol

by Ayala Sample Kits, S.L. Spain EUDAMED

Ref 8SIBOLOLModel 7ATFRU, 7ATLAC, 7ATSAC, 7SIBOGLU, 7SIBOLOL, 7ATSOR, 8ATFRU, 8ATLAC, 8ATSAC, 8SIBOGLU, 8SIBOLSA, 8SIBOLOL, 8ATGAL, 8ATSOR, 8ATXOL, S8ATFRU, S8SIBOGLU, S8ATXIL, ATFRU, ATFRSO, ATGAL, ATLAC, ATSAC, SIBOGLU, SIBOLOL, SIBOLSA, CAL016.1-3, CAL018.1-10, etc EMDN W05019099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8437026387AIRTESTT8 Basic UDI-DIDate17 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Kit Airtest
Model / Reference
7ATFRU, 7ATLAC, 7ATSAC, 7SIBOGLU, 7SIBOLOL, 7ATSOR, 8ATFRU, 8ATLAC, 8ATSAC, 8SIBOGLU, 8SIBOLSA, 8SIBOLOL, 8ATGAL, 8ATSOR, 8ATXOL, S8ATFRU, S8SIBOGLU, S8ATXIL, ATFRU, ATFRSO, ATGAL, ATLAC, ATSAC, SIBOGLU, SIBOLOL, SIBOLSA, CAL016.1-3, CAL018.1-10, etc
Primary DI / UDI-DI
08436628290189
Basic UDI-DI
8437026387AIRTESTT8
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000037853

Other devices from Ayala Sample Kits, S.L.

See all devices from Ayala Sample Kits, S.L. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 7a1fd5a1-eefb-41cc-b272-25b56a99521f 61 fields · synced 22 Oct 2026