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At-home Lab Testing

by biosurfit SA Portugal EUDAMED

Ref AHLT_004Model AHLTTU

EMDN W05010280

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number56006094490AHLTTU49 Basic UDI-DIDate22 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Lab in the Box
Model / Reference
AHLTTU, AHLT_004
Primary DI / UDI-DI
05600218925024
Basic UDI-DI
56006094490AHLTTU49
EMDN Code
W05010280 Urine collection devices - accessories
Device Class
Class A
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
PT-MF-000033920

Other devices from biosurfit SA

See all devices from biosurfit SA →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED a30ecd38-fd10-4b26-818a-0c951b811a4c 61 fields · synced 22 Oct 2026