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Fms

by Feel Tech Bio Co., Ltd. EUDAMED

Active European Union

Ref FIS-080BModel Insulin Syringe Series

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000451001MU Basic UDI-DIDate10 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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 Single-use Insulin Syringe
Model / Reference
Insulin Syringe Series, FIS-080B
Primary DI / UDI-DI
08800045107632
Basic UDI-DI
88000451001MU
EMDN Code
A02010601 Insulin syringes with fixed needle, single-use
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000032555
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Feel Tech Bio Co., Ltd.

See all devices from Feel Tech Bio 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