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SOL-CARE Safety Winged Infusion Set

by Sol-Millennium Medical, Inc. 3 variants

Ref 213412SIModel Safety Blood Collection/Infusion Butterfly Needles with Luer Cap, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without)

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-00818392018288 Basic UDI-DI 00818392018288UDI-DIDate5 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00818392018288 UDI-DI Date3 Jul 2018ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Basic intravenous administration set, invasive
Model / Reference
Safety Blood Collection/Infusion Butterfly Needles with Luer Cap, 213412SI, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without)
Primary DI / UDI-DI
00818392018288
Basic UDI-DI
B-00818392018288, 081006243SBC1YC
Direct Marketing DI
00818392018288
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
GUDID distribution status
In Commercial Distribution
Size
Length — 20 Millimeter
Needle Gauge — 21 Gauge

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

  • 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