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SOL-CARE Safety Needle

by Sol-Millennium Medical, Inc. 22 variants

Ref SN2215Model 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 ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123684↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081006243SND12E Basic UDI-DI 00818392010558UDI-DIDate31 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00818392010558 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK123684 Date8 May 2013IssuedStatusActive

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

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1454-2020 FDA Class II initiated 15 Jan 2020
    • Terminated Z-1455-2020 FDA Class II initiated 15 Jan 2020

    Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.

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  • Withdrawn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

Generic Name
Hypodermic needle, single-use
Model / Reference
Safety Needle, SN2215
Primary DI / UDI-DI
00818392010558
Basic UDI-DI
081006243SND12E
Direct Marketing DI
00818392010558
FDA Product Code
FMI
EMDN Code
A0101010101 Hypodermic syringe needles, with safety systems
GMDN Term
Hypodermic needle, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5570
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 22 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

Related devices

Category: Hypodermic needle, single-use

Other devices from Sol-Millennium Medical, Inc.

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

Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • Prescription Use
  • 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
  • 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