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Sterile hypodermic syringe for single use with needle

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

Ref 100000000373Model three - piece, middle head and a luer slip connector, normal wall and long 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212857↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697135228YZ03000001H8 Basic UDI-DI 06971352286135UDI-DIDate15 Apr 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK212857 Date9 May 2023IssuedStatusActive

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 25 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  • Withdrawn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 and a luer slip connector, normal wall and long cutting edge, 100000000373
Primary DI / UDI-DI
06971352286135
Basic UDI-DI
697135228YZ03000001H8
EMDN Code
A020102010201 Infusion and irrigation syringes, luer 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

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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