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Isis

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 504006

by inomed Medizintechnik GmbH

Identity

Trade Name
ISIS Xpress System für individuelle Konfiguration EUDAMED
ISIS FDA UDI
Generic Name
Nerve-function monitor FDA UDI
Device Name
ISIS Xpress System EUDAMED
ISS Xpress FDA UDI
Model / Reference
504006 EUDAMEDFDA UDI
Description
ISS Xpress FDA UDI

Identifiers

Primary DI / UDI-DI
04250307601424 EUDAMEDFDA UDI
Basic UDI-DI
42503076IGI02037 EUDAMED
FDA Product Code
GWF FDA UDI
EMDN Code
Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
GMDN Term
Nerve-function monitor FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
882.1870 FDA UDI
Medical Purpose
The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations: Measurement: Auditory evoked potentials (AEP), Electroencephalography (EEG), Electrocorticography (ECoG), Electromyography (EMG), Somatosensory evoked potentials (SSEP),Motor evoked potentials (MEP), Visual evoked potentials (VEP), Microelectrode recording (MER), Bladder pressure measurement for pelvic neuromonitoring (pIONM), Train of Four (TOF) Stimulation: Transcranial electrical stimulation (TES), Direct cortical and subcortical stimulation (DCS), Direct nerve stimulation (DNS), Transcutaneous intraoperative nerve stimulation (TINS), Direct muscle stimulation (DMS), Stimulation for visual evoked potentials (VEP) EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nerve-function monitor

Isis by inomed Medizintechnik GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Nerve-function monitor.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
inomed Medizintechnik GmbH

Sources (2)

  • FDA UDI b3430159-d456-44b7-8240-6da408e32c70 33 fields · synced Jul 28, 2026
  • EUDAMED a2edc573-aa53-4a68-be7b-95901027e1c8 61 fields · synced Jul 28, 2026