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SOL-GUARDTM Safety Pull-Button Blood Collection Set with Luer Adapter 23G*3/4*12 PBLA2312

by Sol-Millennium Medical, Inc. EUDAMEDGUDID

Active European Union

Ref PBLA2312

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081006243SPB12J Basic UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810018092672 UDI-DIDate26 Mar 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
SOL-GUARD Safety Pull-button Blood Collection Set with Luer Adapter EUDAMED
SOL-GUARDTM Safety Pull-Button Blood Collection Set with Luer Adapter 23G*3/4*12 GUDID
Generic Name
Blood collection set, invasive
Device Name
Safety Pull-Button Blood Collection/Infusion Set
Model / Reference
PBLA2312
Primary DI / UDI-DI
00810018092672
Basic UDI-DI
081006243SPB12J
Direct Marketing DI
00810018092672
FDA Product Code
JKA
EMDN Code
A01010201 Butterfly needles, with safety systems
GMDN Term
Blood collection set, invasive
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
862.1675
Market of Registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Sol-Millennium Medical, Inc.

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

Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No