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SOL-CARE Luer Lock Syringe with Safety Needle

by Sol-Millennium Medical, Inc. 8 variants

Ref 32515SNModel Standard Luer Lock Syringe with Safety Needle

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241821↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081006243SSC93L Basic UDI-DI 00810018098162UDI-DIDate20 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810018098162 UDI-DI Date30 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK241821 Date20 Sep 2024IssuedStatusActive

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 found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
SOL-CARE Luer Lock Syringe with Safety Needle EUDAMED
SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 1/2'' GUDID
Generic Name
General-purpose syringe, single-use
Model / Reference
Standard Luer Lock Syringe with Safety Needle, 32515SN
Primary DI / UDI-DI
00810018098162
Basic UDI-DI
081006243SSC93L
Direct Marketing DI
00810018098162
510(k) Number
FDA Product Code
FMI, FMF, MEG
EMDN Code
A020102020101 Infusion and irrigation syringes, luer lock cone, 3-piece with needle, single-use
GMDN Term
General-purpose syringe, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5570, 880.5860
EU 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

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
  • Measuring Function
  • 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
  • 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