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SOL-CARE Safety Winged Infusion Set

by Sol-Millennium Medical, Inc. United States EUDAMEDGUDID

Ref 253412SIModel Safety Blood Collection/Infusion Butterfly Needles with Luer Cap, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without) Product code JKAEMDN A01010201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-00818392018301 Basic UDI-DIDate24 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00818392018301 UDI-DIDate3 Jul 2018ListedStatusIn 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Basic intravenous administration set, invasive
Model / Reference
Safety Blood Collection/Infusion Butterfly Needles with Luer Cap, 253412SI, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without)
Primary DI / UDI-DI
00818392018301
Basic UDI-DI
B-00818392018301, 081006243SBC1YC
Direct Marketing DI
00818392018301
FDA Product Code
JKA, FPA
EMDN Code
A01010201 Butterfly needles, with safety systems
GMDN Term
Basic intravenous administration set, invasive
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
862.1675, 880.5440
Market of Registration
Poland
Commercial Distribution
In Commercial Distribution
Size
Needle Gauge — 25 Gauge
Length — 20 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000010890
Authorised representative
Sol-Millennium Europe Sp. z o.o. PL-AR-000010397

Other devices from Sol-Millennium Medical, Inc.

See all devices from Sol-Millennium Medical, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Administering Medicine YesEUDAMEDNoEUDAMED
  • Prescription Use
  • Lot / Batch Number
  • Expiration 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED b4a7c2aa-6ede-4750-a738-74ff11477b81 61 fields · synced 22 Oct 2026
  • FDA UDI 16aa2365-dbde-4a39-8e0f-30b02ef6d622 35 fields · synced 29 May 2026
  • EUDAMED 00818392018301|081006243SBC1YC 61 fields · synced 18 Jul 2026