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Kbmed

by Zhejiang INI Medical Devices Co., Ltd. 7 variants

Ref Y10033108Model U-100 0.3ml 31Gx5/16"（0.25x8mm）

Active European Union

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06941899389965 Basic UDI-DI 06941899389965UDI-DIDate14 Oct 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Sterile Insulin Syringes for single use
Model / Reference
U-100 0.3ml 31Gx5/16"（0.25x8mm）, Y10033108
Primary DI / UDI-DI
06941899389965
Basic UDI-DI
B-06941899389965
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.

See all 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