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Syringe with Needle

by Jiangsu Micsafe Medical Technology Co., Ltd 31 variants

Ref SY03C3SDN2158Model Luer Slip 3ml 21G*5/8”

Active European Union. Also listed in GUDID (US).

CE MDD

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

Overview

This sterile syringe with needle is a medical device designed for the administration of injections. It features a 3ml capacity, a Luer Slip design, and a safe and reliable way to deliver medication or nutrients into the body. The syringe is made from durable materials and is available in a range of sizes to accommodate different user needs.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06971911295028 Basic UDI-DI 06971911295028UDI-DIDate9 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971911295028 UDI-DI Date4 Nov 2021ListedStatusListed 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Syringe with Needle EUDAMED
Micsafe GUDID
Generic Name
General-purpose syringe/needle
Model / Reference
Luer Slip 3ml 21G*5/8” EUDAMED
SY03C3SDN2158 EUDAMED
1 GUDID
Primary DI / UDI-DI
06971911295028
Basic UDI-DI
B-06971911295028
FDA Product Code
FMI, MEG, FMF
EMDN Code
A020102010201 Infusion and irrigation syringes, luer cone, 3-piece with needle, single-use
GMDN Term
General-purpose syringe/needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5570, 880.5860
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Luer Slip 3ml 21G*5/8”
SY03C3SDN2158
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000011594
Authorised representative
Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133

Other devices from Jiangsu Micsafe Medical Technology Co., Ltd

See all devices from Jiangsu Micsafe Medical Technology Co., Ltd →

Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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