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SOL-CARE Luer Lock Syringe with Safety Needle

by Sol-Millennium Medical, Inc. 8 variants

Ref 12510SNModel Standard Luer Lock Syringe with Safety Needle

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 Number081006243SSC93L Basic UDI-DI 10818392018858UDI-DIDate20 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10818392018858 UDI-DI Date23 Oct 2017ListedStatusListed 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  • Withdrawn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

Trade Name
SOL-CARE Luer Lock Syringe with Safety Needle EUDAMED
SOL-CARE™ Luer Lock Syringe w/Safety Needle GUDID
Generic Name
General-purpose syringe, single-use
Model / Reference
Standard Luer Lock Syringe with Safety Needle, 12510SN
Primary DI / UDI-DI
10818392018858 EUDAMED
00818392012002 GUDID
Basic UDI-DI
081006243SSC93L
Direct Marketing DI
10818392018858
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
Size
Length — 25 Millimeter
Total Volume — 1 Milliliter
Needle Gauge — 25 Gauge

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10818392018858
GUDID
00818392012002
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
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No