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GBUK Sterile Syringe

by Jiangsu Micsafe Medical Technology Co., Ltd 7 variants

Ref 3PLS010Model 10ml luer slip

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06971911299217 Basic UDI-DI 06971911299217UDI-DIDate28 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971911299217 UDI-DI Date20 May 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  • Withdrawn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
GBUK Sterile Syringe EUDAMED
Gbuk GUDID
Generic Name
General-purpose syringe, single-use
Model / Reference
10ml luer slip EUDAMED
3PLS010 EUDAMED
1 GUDID
Description
Sterile Syringe 10ML Luer Slip without needle
Primary DI / UDI-DI
06971911299217
Basic UDI-DI
B-06971911299217
FDA Product Code
FMI, MEG, FMF
EMDN Code
A020102010202 Infusion and irrigation syringes, luer cone, 3-piece without 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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
10ml luer slip
3PLS010
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