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Zeus

by Aether Biomedical Spółka z ograniczoną odpowiedzialnością 8 variants

Ref Zeus V1-LModel A-01-L-T

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05904569152291 UDI-DI Date24 Mar 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number59045A-01-L-T8U Basic UDI-DI 05904569152291UDI-DIDate7 Feb 2023RegisteredStatusActive

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  • Withdrawn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
Device Name
Zeus The Bionic Hand
Model / Reference
A-01-L-T, Zeus V1-L
Primary DI / UDI-DI
05904569152291
Basic UDI-DI
59045A-01-L-T8U
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
Poland
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
PL-MF-000005368

Other devices from Aether Biomedical Spółka z ograniczoną odpowiedzialnością

See all devices from Aether Biomedical Spółka z ograniczoną odpowiedzialnością →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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