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Adam's Hand

by BionIT Labs S.r.l. 204 variants

Ref AH02-RM1-N7-01 + WL01-50Model AH02-CDY-EE-WW

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Overview

The Adam's Hand medical device is a portable, non-invasive diagnostic tool designed for early detection and monitoring of endocrine disruptors in human tissues. Its innovative technology allows for rapid and accurate analysis of bodily fluids, providing healthcare professionals with essential information to make informed decisions.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805797159AHY5 Basic UDI-DI 08057971590582UDI-DIDate16 Dec 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
AH02-CDY-EE-WW, AH02-RM1-N7-01 + WL01-50
Primary DI / UDI-DI
08057971590582
Basic UDI-DI
805797159AHY5
EMDN Code
Y061899 Upper extremity prostheses - other
Device Class
Class I
EU 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