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SOL-CARE Safety Winged Infusion Set

by Sol-Millennium Medical, Inc. 17 variants

Ref S193412SIModel Safety Blood Collection/Infusion Butterfly Needles with Luer Cap, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without)

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-00810062439287 Basic UDI-DI 00810062439287UDI-DIDate11 Feb 2026RegisteredStatusActive
European UnionCE/MDD NumberB-00810062439287 Basic UDI-DI 00810062439287UDI-DIDate11 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Model / Reference
Safety Blood Collection/Infusion Butterfly Needles with Luer Cap, S193412SI, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without)
Primary DI / UDI-DI
00810062439287
Basic UDI-DI
B-00810062439287, 081006243SBC1YC
Direct Marketing DI
00810062439287
EMDN Code
A01010201 Butterfly needles, with safety systems
Device Class
Class IIa
EU market of registration
Poland

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

  • 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