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FreedomEdge Infusion Pump - Language Configuration E

by KORU Medical Systems, Inc

Ref F10020-E

Active European Union

CE MDR

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/MDR Number065944301PE Basic UDI-DI 00659443004467UDI-DIDate31 Aug 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
FreedomEdge Infusion Pump
Model / Reference
F10020-E
Primary DI / UDI-DI
00659443004467
Basic UDI-DI
065944301PE
EMDN Code
A99 Devices for administration, withdrawal and collection - other
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000025369
Authorised representative
ICON (LR) Limited IE-AR-000006507

Other devices from KORU Medical Systems, Inc

See all devices from KORU Medical Systems, Inc →

Properties

  • Administering Medicine
  • Measuring Function

Other properties (11)

  • 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
  • Incorporates Medicinal Product: No