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Kbmed

by Zhejiang INI Medical Devices Co., Ltd. EUDAMED

Active European Union

Ref Y10053108Model U-100 0.5ml 31Gx5/16"（0,25x8mm）

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06941899391340 Basic UDI-DIDate27 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

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.

Specification

EUDAMED

Device Name
Sterile Insulin Syringes for single use
Model / Reference
U-100 0.5ml 31Gx5/16"（0, 25x8mm）, Y10053108
Primary DI / UDI-DI
06941899391340
Basic UDI-DI
B-06941899391340
EMDN Code
A02010601 Insulin syringes with fixed needle, single-use
Device Class
Class IIa
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

Properties

  • Sterile
  • Administering Medicine

Other properties (9)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No