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VELLAP Strep A

by VELLAP Diagnostics GmbH Germany EUDAMED

Ref 2.13.6.6

EMDN W0105011101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04260743470546 Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
2.13.6.6
Primary DI / UDI-DI
04260743470546
Basic UDI-DI
B-04260743470546
EMDN Code
W0105011101 Streptococcal direct antigen detection
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000035636

Other devices from VELLAP Diagnostics GmbH

See all devices from VELLAP Diagnostics GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 5c1418d7-7ebc-4174-b68a-3b4f16ea40c6 61 fields · synced 24 Oct 2026