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Zeus

by Aether Biomedical Spółka z ograniczoną odpowiedzialnością 8 variants

Ref A02L-SF0B, Zeus V 1-L, A02L-MF0B, A-01-L Zeus V 1, A02L-SF1BModel A02L-SF0B; A02R-SF0B; A02L-MF0B; A02R-MF0B, A02L-SF1B, A02R-SF1B; A02L-MF1B, A02R-MF1B, A-01-L-TS-S, A-01-L

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number59055153406A02T2 Basic UDI-DI Date3 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05905515340618 UDI-DI Date15 Apr 2022ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Electrical hand prosthesis
Myoelectric hand prosthesis
Device Name
Zeus Bionic Hand [Zeus V2]
Zeus The Bionic Hand
Model / Ref / Catalog
A02L-SF0B, A02R-SF0B, A02L-MF0B, A02R-MF0B, A02L-SF1B, A02R-SF1B, A02L-MF1B, A02R-MF1B, A-01-L-TS-S, Zeus V 1-L, A-01-L, A-01-L Zeus V 1, Zeus V1
Primary DI / UDI-DI
05905515340618, 05905515340243, 05905515340717, 05904569152208, 05905515340755
Basic UDI-DI
59055153406A02T2, 59055A-01-L-TS-S3P, 59045691522A-01-LNS
FDA Product Code
IQZ
EMDN Code
Y061899 Upper extremity prostheses - other
GMDN Term
Electrical hand prosthesis
Myoelectric hand prosthesis
Device Class
Class I
Regulation Number
890.3420
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Manufacturer details

EUDAMED SRN
PL-MF-000005368

Other devices from Aether Biomedical Spółka z ograniczoną odpowiedzialnością

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Properties

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

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No