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Sterile Hypodermic Syringes for Single Use (with needle)

by Jiangsu Zhengkang Medical Apparatus Co., Ltd. 34 variants

Ref 20ml21G×11/2”, 5ml21G×11/4”, 2ml23G×11/4”, 10ml21G×11/2”, 5ml21G×11/2”, 20ml23G×1”, 20ml20G×11/2”, 10ml23G×1”, 3ml23G×11/2”, 10ml18G×11/2”, 10ml22G×11/2”, 5ml23G×11/2”, 50ml21G×11/2”, 1ml25G×1/2”, 5ml23G×11/4”, 3ml23G×11/4”, 30ml16G×11/2”, 2ml23G×11/2”, 60ml16G×11/2”, 30ml18G×11/2”, 30ml21G×11/2”, 5ml22G×11/2”, 2ml21G×11/2”, 50ml18G×11/2”, 10ml23G×11/2”, 3ml21G×11/2”, 20ml18G×11/2”, 50ml16G×11/2”, 10ml22G×11/4”, 1ml27G×1/2”Model Sterile Hypodermic Syringes for Single Use (with Needle)-luer lock, Sterile Hypodermic Syringes for Single Use (with Needle)-two-piece, Sterile Hypodermic Syringes for Single Use (with Needle)-luer slip

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252279↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK252279 Date17 Apr 2026IssuedStatusActive
European UnionCE/MDR EUDAMED Number695312468201G6 Basic UDI-DI Date8 Sep 2023RegisteredStatusActive

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

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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)

Model / Reference
Sterile Hypodermic Syringes for Single Use (with Needle)-luer lock, 20ml21G×11/2”, Sterile Hypodermic Syringes for Single Use (with Needle)-two-piece, 5ml21G×11/4”, Sterile Hypodermic Syringes for Single Use (with Needle)-luer slip, 2ml23G×11/4”, 10ml21G×11/2”, 5ml21G×11/2”, 20ml23G×1”, 20ml20G×11/2”, 10ml23G×1”, 3ml23G×11/2”, 10ml18G×11/2”, 10ml22G×11/2”, 5ml23G×11/2”, 50ml21G×11/2”, 1ml25G×1/2”, 5ml23G×11/4”, 3ml23G×11/4”, 30ml16G×11/2”, 2ml23G×11/2”, 60ml16G×11/2”, 30ml18G×11/2”, 30ml21G×11/2”, 5ml22G×11/2”, 2ml21G×11/2”, 50ml18G×11/2”, 10ml23G×11/2”, 3ml21G×11/2”, 20ml18G×11/2”, 50ml16G×11/2”, 10ml22G×11/4”, 1ml27G×1/2”
Primary DI / UDI-DI
06953124625120, 06953124630100, 06953124611079, 06953124631121, 06953124613165, 06953124625021, 06953124632166, 06953124624024, 06953124622082, 06953124614247, 06953124614087, 06953124614025, 06953124630032, 06953124627124, 06953124620101, 06953124613073, 06953124617125, 06953124622075, 06953124626202, 06953124687111, 06953124630025, 06953124618283, 06953124687319, 06953124616166, 06953124631084, 06953124626042, 06953124621085, 06953124613127, 06953124616043, 06953124630070, 06953124621160, 06953124623089, 06953124612076, 06953124626165, 06953124617248, 06953124631046, 06953124614124, 06953124622167, 06953124632241, 06953124617286, 06953124623164, 06953124687104, 06953124631077, 06953124620002, 06953124627247, 06953124624246, 06953124611161, 06953124615121, 06953124687197, 06953124624048
Basic UDI-DI
695312468201G6, 695312468701GX, 695312461000E9
EMDN Code
A020102020101, A020102010101, A020102010201
Device Class
Class IIa
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000037484
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jiangsu Zhengkang Medical Apparatus Co., Ltd.

See all devices from Jiangsu Zhengkang Medical Apparatus Co., Ltd. →

Properties

  • Sterile
  • Administering Medicine YesEUDAMEDNoEUDAMED

Other properties (11)

  • 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