Skip to content

SOL-CARE Safety Blood Collection Needle

by Sol-Millennium Medical, Inc. United States EUDAMEDGUDID

Ref 110201030030, 110201030030 Model Safety Blood Collection Needle, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without)

Product code FPAEMDN A01010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-10818392017257 Basic UDI-DIDate6 Jun 2023RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-10818392017257 Basic UDI-DIDate6 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number10818392017257 UDI-DIDate26 Jun 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD 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
Needle guard
Model / Reference
Safety Blood Collection Needle, 110201030030, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without)
Primary DI / UDI-DI
10818392017257, 00818392017250
Basic UDI-DI
B-10818392017257, 081006243SBC1YC
Direct Marketing DI
00818392017250
FDA Product Code
FPA, JKA
EMDN Code
A01010201 Butterfly needles, with safety systems
GMDN Term
Needle guard
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5440, 862.1675
Market of Registration
Poland
Commercial Distribution
In Commercial Distribution
Size
Needle Gauge — 21 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

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (19)
  • 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
  • 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 9657b88c-ff92-4c42-b11e-bb04286c5f55 61 fields · synced 22 Oct 2026
  • FDA UDI 9a1a03ae-bc35-438d-9777-b11f938e2e3e 35 fields · synced 25 May 2026
  • EUDAMED 00818392017250|081006243SBC1YC 61 fields · synced 13 Oct 2026