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Sterile hypodermic syringe for single use with needle

by Wuxi Yushou Medical Appliances Co., Ltd. 134 variants

Ref 100000000359Model three-piece, middle head luer lock,thin-walled and short cutting edge

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) K090929↗

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
European UnionCE/MDR EUDAMED Number697135228YZ03010004HR Basic UDI-DI 06971352289822UDI-DIDate3 May 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK090929 Date12 Jun 2009IssuedStatusActive

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  • Withdrawn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
three-piece, middle head luer lock, thin-walled and short cutting edge, 100000000359
Primary DI / UDI-DI
06971352289822
Basic UDI-DI
697135228YZ03010004HR
EMDN Code
A020102020101 Infusion and irrigation syringes, luer lock cone, 3-piece with needle, single-use
Device Class
Class IIa
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
CN-MF-000017951
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Wuxi Yushou Medical Appliances Co., Ltd.

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Properties

  • Sterile
  • Implantable
  • Administering Medicine

Other properties (10)

  • 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