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Galaxy II

by Mosaic Surgical Ltd United Kingdom EUDAMEDGUDID

Ref JUNEGX-2020Model JUNE3000

Product code FFOEMDN L03140101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number15060557440164 UDI-DIDate26 Mar 2026ListedStatusIn distribution
European UnionCE/MDD EUDAMED NumberB-15060557440164 Basic UDI-DIDate10 Nov 2021RegisteredStatusActive

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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Galaxy II EUDAMED
Galaxy II Surgical Retractor EUDAMEDGUDID
Generic Name
Surgical retraction system, single-use
Device Name
Galaxy II Snowman Male Pack
Galaxy II Snowman Frame
Model / Reference
JUNEGX-2020, JUNE3000
Primary DI / UDI-DI
15060557440164
Basic UDI-DI
B-15060557440164, 506055744AAA000R7
Direct Marketing DI
15060557440164
FDA Product Code
FFO, KAL, HDL, GAD
EMDN Code
L03140101, K01020106
GMDN Term
Surgical retraction system, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
876.4730, 874.4420, 884.4520, 878.4800
Market of Registration
Northern Ireland
Sweden
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
GB-MF-000003512
Authorised representative
JUNE Medical Sverige AB SE-AR-000001906

Other devices from Mosaic Surgical Ltd

See all devices from Mosaic Surgical Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (18)
  • 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

Sources (3)

  • EUDAMED f8e254a8-e4fd-4ecb-911e-769c9786077d 61 fields · synced 22 Oct 2026
  • EUDAMED 15060557440164|506055744AAA000R7 61 fields · synced 17 May 2026
  • FDA UDI 6648afbc-654c-40a4-8fc6-0fa5e0694de8 33 fields · synced 23 Oct 2026