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Galaxy II

by Mosaic Surgical Ltd United Kingdom EUDAMEDGUDID

Ref LClip4000, GX10, JUNE3003B-8, JUNEGX-2023, GX30, GClip3000Model JUNE3000

Product code KALEMDN L03140199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberD-5060557440310V3 UDI-DIDate9 Apr 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED NumberB-5060557440310V3 Basic UDI-DIDate15 Nov 2021RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-5060557440310V3 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 mounting frame, single-use
Surgical retraction system, single-use
Medical/surgical interventional tube/cable securement clip, single-use
Surgical retractor/retraction system blade, single-use
Device Name
Galaxy II Snowman Frame
Galaxy II Catheter/Drain Clip
Model / Reference
LClip4000, JUNE3000, GX10, JUNE3003B-8, JUNEGX-2023, GX30, GClip3000
Primary DI / UDI-DI
D-5060557440310V3, 15060557440423, 15060557440317, 65060557440060, 45060557440417, 15060557440447, D-5060557440020UP
Basic UDI-DI
B-5060557440310V3, 506055744AAA000R7, B-5060557440020UP
Direct Marketing DI
15060557440317
65060557440060
45060557440417
FDA Product Code
KAL, HDL, FFO, GAD
EMDN Code
L03140199, K01020106, K01020114, K01020112
GMDN Term
Surgical retraction system mounting frame, single-use
Surgical retraction system, single-use
Medical/surgical interventional tube/cable securement clip, single-use
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

Related devices

Category: Hand-held surgical retractor, reusable

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 (12)

  • EUDAMED a58d5813-bdc9-480f-b685-2f7d9daf9dd8 61 fields · synced 22 Oct 2026
  • EUDAMED 15060557440423|506055744AAA000R7 61 fields · synced 17 May 2026
  • EUDAMED 15060557440317|506055744AAA000R7 61 fields · synced 17 May 2026
  • EUDAMED 65060557440060|506055744AAA000R7 61 fields · synced 18 May 2026
  • EUDAMED 45060557440417|506055744AAA000R7 61 fields · synced 18 May 2026
  • EUDAMED 15060557440447|506055744AAA000R7 61 fields · synced 19 May 2026
  • EUDAMED D-5060557440020UP|B-5060557440020UP 61 fields · synced 19 May 2026
  • FDA UDI ffb563fb-bacd-4096-829c-f0813889ffb5 33 fields · synced 23 Oct 2026
  • FDA UDI c6493d1b-5109-4ca0-adb7-edd7f1f54f43 33 fields · synced 23 Oct 2026
  • FDA UDI a41ec4b8-2e4a-44e0-82d1-0b0c36f946ce 33 fields · synced 23 Oct 2026
  • FDA UDI d98030e3-880c-4e5b-a9d9-a26945d23507 33 fields · synced 23 Oct 2026
  • FDA UDI d722420b-b9bc-4db8-be8c-122264dba823 33 fields · synced 23 Oct 2026