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SOL-M Insulin Syringe with Fixed Needle

by Sol-Millennium Medical, Inc.

Ref 1633051Model Insulin Standard Syringe with fixed 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081006243INS1ZJ Basic UDI-DI 00818392010763UDI-DIDate8 Jan 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00818392010763 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  • Withdrawn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

Trade Name
SOL-M Insulin Syringe with Fixed Needle EUDAMED
SOL-M™ U-100 Insulin Syringe with Fixed Needle GUDID
Generic Name
Insulin syringe/needle, basic
Model / Reference
Insulin Standard Syringe with fixed needle EUDAMED
1633051 EUDAMED
16330516 GUDID
Primary DI / UDI-DI
00818392010763
Basic UDI-DI
081006243INS1ZJ
Direct Marketing DI
00818392010763
FDA Product Code
FMF
EMDN Code
A02010601 Insulin syringes with fixed needle, single-use
GMDN Term
Insulin syringe/needle, basic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5860
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Size
Length — 8 Millimeter
Total Volume — 0.3 Milliliter
Needle Gauge — 30 Gauge

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Insulin Standard Syringe with fixed needle
1633051
GUDID
16330516
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
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

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