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Lumo Socket A-2 v1.0

by macu4 GmbH Germany EUDAMEDGUDID

Ref 4262429650549 Product code ISSEMDN Y0699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426242965P030206RR Basic UDI-DIDate18 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04262429650549 UDI-DIDate18 Jul 2026ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaNorwayNorwayIcelandNorwaySwedenFinlandFinlandNorwaySwedenFinlandFinlandNorwaySwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceLiechtensteinAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaMalta
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

EU market availability

Available in 29 countries, as listed in EUDAMED:

  • Austria since 18 Jul 2026
  • Belgium since 18 Jul 2026
  • Bulgaria since 18 Jul 2026
  • Croatia since 18 Jul 2026
  • Czechia since 18 Jul 2026
  • Denmark since 18 Jul 2026
  • Estonia since 18 Jul 2026
  • Finland since 18 Jul 2026
  • France since 18 Jul 2026
  • Germany since 18 Jul 2026
  • Hungary since 18 Jul 2026
  • Iceland since 18 Jul 2026
  • Ireland since 18 Jul 2026
  • Italy since 18 Jul 2026
  • Latvia since 18 Jul 2026
  • Liechtenstein since 18 Jul 2026
  • Lithuania since 18 Jul 2026
  • Luxembourg since 18 Jul 2026
  • Malta since 18 Jul 2026
  • Netherlands since 18 Jul 2026
  • Northern Ireland since 18 Jul 2026
  • Norway since 18 Jul 2026
  • Poland since 18 Jul 2026
  • Portugal since 18 Jul 2026
  • Romania since 18 Jul 2026
  • Slovakia since 18 Jul 2026
  • Slovenia since 18 Jul 2026
  • Spain since 18 Jul 2026
  • Sweden since 18 Jul 2026

Last checked 25 Oct 2026.

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 25 Oct 2026

Trade Name
Lumo Socket A-2
Generic Name
Passive hand prosthesis
Device Name
Lumo Socket
Model / Ref / Catalog
4262429650549 EUDAMED
v1.0 GUDID
03081002x GUDID
Primary DI / UDI-DI
04262429650549
Basic UDI-DI
426242965P030206RR
Direct Marketing DI
04262429650549
FDA Product Code
ISS
EMDN Code
Y0699 External prostheses and orthoses - other
GMDN Term
Passive hand prosthesis
Device Class
Class I
Regulation Number
890.3420
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
4262429650549
GUDID
v1.0

Other devices from macu4 GmbH

See all devices from macu4 GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date
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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No

Sources (2)

  • FDA UDI d400c0ec-3c17-4b84-8900-5b44e2d1f0f1 33 fields · synced 25 Oct 2026
  • EUDAMED 04262429650549|426242965P030206RR 61 fields · synced 25 Oct 2026