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Anti-Fyb AGT method

by Sanquin Reagents B.V. EUDAMED

Active European Union

Ref K1337

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08720682030851 Basic UDI-DIDate20 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Anti-Fyb AGT method
Model / Reference
K1337
Primary DI / UDI-DI
08720682030851
Basic UDI-DI
B-08720682030851
EMDN Code
W0103030501 Other antigen typing reagents
Device Class
Class IVD Annex II List B
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000000530

Other devices from Sanquin Reagents B.V.

Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (5)

  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No