Skip to content

Al-109

by Ansh Labs United States EUDAMED

Ref AL-109-I - PAPP-A2 ELISAModel AL-109 EMDN W0102050299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-AL-1092M Basic UDI-DIDate23 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Al-109-I - Papp-A2 Elisa
Model / Reference
AL-109, AL-109-I - PAPP-A2 ELISA
Primary DI / UDI-DI
D-AL-1092M
Basic UDI-DI
B-AL-1092M
EMDN Code
W0102050299 Pregnancy testing hormones - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000054510
Authorised representative
QNET B.V. NL-AR-000002695

Other devices from Ansh Labs

See all devices from Ansh Labs →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 0296520d-ee1a-42e4-bba9-9da8144a89ae 61 fields · synced 25 Oct 2026