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Sterile insulinsyringe for single use

by Zhejiang INI Medical Devices Co., Ltd.

Ref Y10052913, NOModel U-100 0.5ml 29Gx1/2"（0,33x12.7mm）, 0.3mL,0.5mL,1mL

Active European Union

CE MDR CE MDD

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 NumberB-06941899391357 Basic UDI-DI 06941899391357UDI-DIDate27 Aug 2026RegisteredStatusActive
European UnionCE/MDD NumberB-06941899391357 Basic UDI-DI 06941899391357UDI-DIDate27 Aug 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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Sterile insulinsyringe for single use
Sterile Insulin Syringes for single use
Model / Reference
U-100 0.5ml 29Gx1/2"（0, 33x12.7mm）, Y10052913, 0.3mL, 0.5mL, 1mL, NO
Primary DI / UDI-DI
06941899391357
Basic UDI-DI
B-06941899391357, 69418993YSQ025G
EMDN Code
A02010601 Insulin syringes with fixed needle, single-use
Device Class
Class IIa
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000025543
Authorised representative
Caretechion GmbH DE-AR-000005946

Other devices from Zhejiang INI Medical Devices Co., Ltd.

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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