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Disposable Insulin Syringe

by Jiangsu Zhiyu Medical Instrument Co., Ltd. 2 variants

Ref Rule 6 Sub-clause 1 No IndentModel U-100 syringe U-40 syringe

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69515008ZSQ004TD Basic UDI-DI 06951500878009UDI-DIDate4 Sep 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Disposable Insulin Syringe
Model / Reference
U-100 syringe U-40 syringe, Rule 6 Sub-clause 1 No Indent
Primary DI / UDI-DI
06951500878009
Basic UDI-DI
69515008ZSQ004TD
EMDN Code
A02010601 Insulin syringes with fixed needle, single-use
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000024555
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Jiangsu Zhiyu Medical Instrument Co., Ltd

See all devices from Jiangsu Zhiyu Medical Instrument Co., Ltd →

Properties

  • Sterile
  • Administering Medicine

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