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Galaxy II

by Mosaic Surgical Ltd United Kingdom EUDAMEDGUDID

Ref JUNE3003B-100Model JUNE3000

Product code KALEMDN L03140104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number25060557440062 UDI-DIDate9 Apr 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED NumberB-25060557440062 Basic UDI-DIDate10 Nov 2021RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-25060557440062 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
  • 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 retractor/retraction system blade, single-use
Device Name
Galaxy II 12 Blunt Stays
Galaxy II Snowman Frame
Model / Reference
JUNE3003B-100, JUNE3000
Primary DI / UDI-DI
25060557440062
Basic UDI-DI
B-25060557440062, 506055744AAA000R7
Direct Marketing DI
25060557440062
FDA Product Code
KAL, HDL, FFO, GAD
EMDN Code
L03140104, K01020112
GMDN Term
Surgical retractor/retraction system blade, 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 9b685a17-4d50-4943-8733-1c02c633409e 61 fields · synced 22 Oct 2026
  • EUDAMED 25060557440062|506055744AAA000R7 61 fields · synced 18 May 2026
  • FDA UDI 11745a4f-558c-401f-b696-ea933df415c2 33 fields · synced 23 Oct 2026