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Adam's Hand

by BionIT Labs S.r.l. 204 variants

Ref AH02-RM3-N2-01 + WL03-45Model 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 24 Oct 2026. What this means

Overview

Meet Adam's Hand, a cutting-edge medical device designed to simplify hand surgery procedures. This innovative device features a unique instrument and endocrine disruptor, making it an effective solution for surgeons. With advanced testing capabilities and a focus on patient safety, Adam's Hand has earned a reputation as a reliable tool in the medical field.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805797159AHY5 Basic UDI-DI 08057971592067UDI-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  • Withdrawn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-RM3-N2-01 + WL03-45
Primary DI / UDI-DI
08057971592067
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