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Adam's Hand

by BionIT Labs S.r.l. 20 variants

Ref AH02-RM3-B1-01Model AH02-CDY-EE-WW

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Overview

At Adam's Hand, we've revolutionized hand surgery with our innovative BionIT Labs S.r.l. developed device. With advanced sterility and a secure packaging process, this medical device has gained worldwide recognition for its high-quality outcomes.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08057971592463 UDI-DI Date21 Nov 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number805797159AHY5 Basic UDI-DI 08057971592463UDI-DIDate16 Dec 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Myoelectric hand prosthesis
Model / Reference
AH02-CDY-EE-WW, AH02-RM3-B1-01
Primary DI / UDI-DI
08057971592463
Basic UDI-DI
805797159AHY5
FDA Product Code
IQZ
EMDN Code
Y061899 Upper extremity prostheses - other
GMDN Term
Myoelectric hand prosthesis
Device Class
Class I
Regulation Number
890.3420
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

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

  • Prescription Use
  • Premarket Exempt
  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No