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GlucoMen Day PUMP Narsha

by EOFLOW Co., Ltd. EUDAMED

Withdrawn Not intended for the EU market

Ref 53518

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000579EOPATCHST Basic UDI-DIDate8 Oct 2024RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

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
Ambulatory Insulin Infusion Pump, electronic
Model / Reference
53518
Primary DI / UDI-DI
08800057900320, 08800057900337
Basic UDI-DI
88000579EOPATCHST
Direct Marketing DI
08800057900320
08800057900337
EMDN Code
Z1204021699 Portable microinfusion instruments - other
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
KR-MF-000019216
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Properties

  • Administering Medicine

Other properties (12)

  • Sterile: No
  • 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