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Al-196

by Ansh Labs United States EUDAMED

Ref AL-196

EMDN W0102050215

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-AL-1963A Basic UDI-DIDate22 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 22 Oct 2026

Device Name
AL-196-I - PCO Check AMH ELISA (CE)
Model / Reference
AL-196
Primary DI / UDI-DI
D-AL-1963A
Basic UDI-DI
B-AL-1963A
EMDN Code
W0102050215 Anti-mullerian hormone
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 0874fd0b-34bc-412b-8f5d-a12f8c5fb4ab 61 fields · synced 22 Oct 2026