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Sterile hypodermic syringe for single use with needle

by Wuxi Yushou Medical Appliances Co., Ltd. 101 variants

Ref 100000000238Model three - piece, middle head and a luer slip connector, normal wall and long cutting edge

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

CE MDR

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/MDR EUDAMED Number697135228YZ03000001H8 Basic UDI-DI 06971352282342UDI-DIDate15 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06971352282342 UDI-DI Date31 Mar 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Sterile hypodermic syringe for single use with needle EUDAMED
Yeso med GUDID
Generic Name
Hypodermic needle, single-use
Model / Reference
three - piece EUDAMED
middle head and a luer slip connector EUDAMED
normal wall and long cutting edge EUDAMED
100000000238 EUDAMED
1ml 0.5×16 GUDID
Primary DI / UDI-DI
06971352282342
Basic UDI-DI
697135228YZ03000001H8
FDA Product Code
FMF, FMI
EMDN Code
A020102010201 Infusion and irrigation syringes, luer cone, 3-piece with needle, single-use
GMDN Term
Hypodermic needle, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5860, 880.5570
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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.

See all devices from Wuxi Yushou Medical Appliances Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Administering Medicine
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No