Skip to content

SOL-CARE Safety Winged Infusion Set

by Sol-Millennium Medical, Inc. United States EUDAMED510(k)

Ref S233412SIModel Safety Blood Collection/Infusion Butterfly Needles with Luer Cap, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without)510(k) K232881 Product code JKAEMDN A01010201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-00810062439256 Basic UDI-DIDate11 Feb 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-00810062439256 Basic UDI-DIDate11 Feb 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK232881 Date22 Dec 2023ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

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

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

Model / Reference
Safety Blood Collection/Infusion Butterfly Needles with Luer Cap, S233412SI, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without)
Primary DI / UDI-DI
00810062439256
Basic UDI-DI
B-00810062439256, 081006243SBC1YC
Direct Marketing DI
00810062439256
EMDN Code
A01010201 Butterfly needles, with safety systems
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
US-MF-000010890
FDA applicant
Jiangsu Kangbao Medical Equipment Co., Ltd.
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
  • Administering Medicine YesEUDAMEDNoEUDAMED
Other properties (11)
  • 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

Sources (3)

  • EUDAMED 09ba48e9-b057-4c61-874c-52959f6ef82d 85 fields · synced 22 Oct 2026
  • EUDAMED 00810062439256|081006243SBC1YC 61 fields · synced 15 Jul 2026
  • FDA 510(k) K232881 1 fields · synced 18 May 2026