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by Medtrum Technologies Inc. China EUDAMED

Ref MD8301, JN-022, MD-JN-012, MD0201, MD8201

EMDN Z120402160101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06971123681497 Basic UDI-DIDate18 Mar 2024RegisteredStatusActive

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

Model / Reference
MD8301, JN-022, MD-JN-012, MD0201, MD8201
Primary DI / UDI-DI
06971123681497, 06971123680599, 06971123680230, 06971123680957, 06971123681091, 06971123680582, 06971123680223, 06971123680605
Basic UDI-DI
B-06971123681497, B-06971123680599, B-06971123680230, B-06971123680957, B-06971123681091, B-06971123680582, B-06971123680223, B-06971123680605
EMDN Code
Z120402160101 Portable insulin microinfusors
Device Class
Class IIb
Market of Registration
Netherlands
Czechia
France

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 (8)

  • EUDAMED d0bdbd2c-973d-4d50-90c0-910cc7478c47 61 fields · synced 22 Oct 2026
  • EUDAMED 06971123680599|B-06971123680599 61 fields · synced 17 May 2026
  • EUDAMED 06971123680230|B-06971123680230 61 fields · synced 17 May 2026
  • EUDAMED 06971123680957|B-06971123680957 61 fields · synced 18 May 2026
  • EUDAMED 06971123681091|B-06971123681091 61 fields · synced 18 May 2026
  • EUDAMED 06971123680582|B-06971123680582 61 fields · synced 19 May 2026
  • EUDAMED 06971123680223|B-06971123680223 61 fields · synced 19 May 2026
  • EUDAMED 06971123680605|B-06971123680605 61 fields · synced 19 May 2026