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Galaxy II

by Mosaic Surgical Ltd United Kingdom EUDAMEDGUDID

Ref JUNEGX-U5SModel JUNE3000

Product code KALEMDN L03140101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number15060557440379 UDI-DIDate26 Mar 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED NumberB-15060557440379 Basic UDI-DIDate15 Nov 2021RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-15060557440379 Basic UDI-DIDate15 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
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • 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 Slider 5mm Sharp Stay Kit
Galaxy II Snowman Frame
Model / Reference
JUNEGX-U5S, JUNE3000
Primary DI / UDI-DI
15060557440379
Basic UDI-DI
B-15060557440379, 506055744AAA000R7
Direct Marketing DI
15060557440379
FDA Product Code
KAL, HDL, FFO, GAD
EMDN Code
L03140101, K01020106
GMDN Term
Surgical retraction system, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
874.4420, 884.4520, 876.4730, 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 c4d1969c-ac24-47a8-a6e9-19fe6bd5ee6b 61 fields · synced 22 Oct 2026
  • EUDAMED 15060557440379|506055744AAA000R7 61 fields · synced 17 May 2026
  • FDA UDI 5952ed59-389c-4d92-8d9e-7637ffb09adc 33 fields · synced 23 Oct 2026