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A8 TouchCare System

by Medtrum Technologies Inc. China EUDAMED

Ref SY-201

EMDN Z120402160101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06971123680919 Basic UDI-DIDate6 Jan 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Insulin Management System
Model / Reference
SY-201
Primary DI / UDI-DI
06971123680919
Basic UDI-DI
B-06971123680919
EMDN Code
Z120402160101 Portable insulin microinfusors
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000001942
Authorised representative
Medtrum B.V. NL-AR-000000595

Other devices from Medtrum Technologies Inc.

See all devices from Medtrum Technologies Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
Other properties (10)
  • Sterile: No
  • 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

Sources (1)

  • EUDAMED ab497828-8f83-4144-a643-4573d2428a22 61 fields · synced 22 Oct 2026