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SOL-CARE Luer Lock Safety Syringe with Exchangeable Needle

by Sol-Millennium Medical, Inc. 28 variants

Ref 100059IMModel SOL-CARE Luer Lock Safety Syringe with Exchangeable 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 Number081006243SSR14H Basic UDI-DI 00818392012811UDI-DIDate25 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00818392012811 UDI-DI Date16 Sep 2016ListedStatusListed 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  • Withdrawn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
Hypodermic needle, single-use
Model / Reference
SOL-CARE Luer Lock Safety Syringe with Exchangeable Needle, 100059IM
Primary DI / UDI-DI
00818392012811
Basic UDI-DI
081006243SSR14H
Direct Marketing DI
00818392012811
FDA Product Code
MEG, FMI, FMF
EMDN Code
A02010205 Infusion and irrigation syringes with safety system, single-use
GMDN Term
Hypodermic needle, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5860, 880.5570
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 3 Milliliter
Needle Gauge — 18 Gauge
Length — 40 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

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