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Analog Amplifier

by BionIT Labs S.r.l. 3 variants

Ref AA03-50-01, AA03-60-01Model 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

None found

in data synced 23 Oct 2026

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08057971594078 UDI-DI Date25 Aug 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number805797159AHY5 Basic UDI-DI Date16 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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

Trade Name
Analog Amplifier EUDAMED
Analog Amplifier with accessories GUDID
Generic Name
Myoelectric hand prosthesis
Device Name
Adam's Hand
Model / Reference
AH02-CDY-EE-WW EUDAMED
AA03-50-01 EUDAMED
AA03-60-01 EUDAMED
AA03-60 GUDID
Primary DI / UDI-DI
08057971594078, 08057971594658, 08057971594085, 08057971594665, 08057971594702
Basic UDI-DI
805797159AHY5
Direct Marketing DI
08057971594078
08057971594085
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AH02-CDY-EE-WW
AA03-50-01
AA03-60-01
GUDID
AA03-60

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