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ISIS MER System Kompakt Komplettsystem

by inomed Medizintechnik GmbH

Ref 590104Model 590102

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42503076FGS0404C Basic UDI-DI 04250307608195UDI-DIDate12 May 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  • Withdrawn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
ISIS MER System Portable
Model / Reference
590102, 590104
Primary DI / UDI-DI
04250307608195
Basic UDI-DI
42503076FGS0404C
EMDN Code
Z121002 Nervous system monitoring systems
Device Class
Class IIa
Medical Purpose
The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations: Measurement:Motor evoked potentials (MEP), Microelectrode recording (MER), Electroencephalography (EEG), Electromyography (EMG).

Manufacturer details

EUDAMED SRN
DE-PR-000019534

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Properties

Other properties (1)

  • Sterile: No