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Kit Para Sibo/Intolerancias Azucares Glucosa

by Ayala Sample Kits, S.L. EUDAMED

Active European Union

Ref CAL018.2Model 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

Regulatory status

as of 27 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  • Withdrawn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

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

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, CAL018.2
Primary DI / UDI-DI
08436628290288
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

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Properties

  • 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