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Adam's Hand

by BionIT Labs S.r.l. EUDAMED

Active European Union

Ref AH02-LM1-B1-01-DModel AH02-CDY-EE-WW

Overview

Introducing Adam's Hand, a innovative medical device designed to provide precise and reliable results in endocrine disruption testing. With its advanced technology and user-friendly interface, this device is perfect for clinicians who require accurate and consistent test outcomes.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805797159AHY5 Basic UDI-DIDate16 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
AH02-CDY-EE-WW, AH02-LM1-B1-01-D
Primary DI / UDI-DI
08057971595297
Basic UDI-DI
805797159AHY5
EMDN Code
Y061899 Upper extremity prostheses - other
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000007793

Other devices from BionIT Labs S.r.l.

See all devices from BionIT Labs S.r.l. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No