FDA.reportPublic FDA data

EMG module

Primary DI
08594211571524
Brand
EMG module
Company
MEDKONSULT medical technology s.r.o.
Model
MU5006-60
Catalog number
MU5006-60
Device description
EMG module used in urodynamics measurement system
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FENDevice, Cystometric, Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FENDevice, Cystometric, HydraulicGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08594211571524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08594211571524085942115715248594211571524

GMDN Terms#

Term, Definition table
TermDefinition
Urodynamic measurement systemAn assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry (measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). Long-term recording may also be analysed.

Regulatory Flags#

DUNS number
361814147
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08594211571548EMG module for UROMIC HarmonyFU9007-60FU9007-602026-10-15
08594211571562DANFLOW Wave - UroflowmeterFU1110-915FU1110-9152026-10-15
08594211571579DANFLOW Wave - UroflowmeterFU1110-BTFU1110-BT2026-10-15
08594211571586DANFLOW Chord - UroflowmeterFU1210FU12102026-10-15
08594211570466ATMOS Air-Charged Pressure SensorPS11-01A252024-11-06
08594211570473ATMOS Air-Charged Pressure SensorPS11-01R252024-11-06
08594211570480ATMOS Air-Charged Pressure SensorPS11-01U252024-11-06
08594211570497ATMOS Air-Charged Pressure SensorPS11-01V252024-11-06
08594211570541ATMOS Air-Charged Pressure SensorPS11-02A052024-11-06
08594211570558ATMOS Air-Charged Pressure SensorPS11-02R052024-11-06
08594211570565ATMOS Air-Charged Pressure SensorPS11-02U052024-11-06
08594211570572ATMOS Air-Charged Pressure SensorPS11-02V052024-11-06
08594211570664ATMOS Air-Charged Pressure SensorPS11-11A052024-11-06
08594211570671ATMOS Air-Charged Pressure SensorPS11-11A252024-11-06
08594211570688ATMOS Air-Charged Pressure SensorPS11-11R052024-11-06
08594211570695ATMOS Air-Charged Pressure SensorPS11-11R252024-11-06
08594211570701ATMOS Air-Charged Pressure SensorPS11-11U052024-11-06
08594211570718ATMOS Air-Charged Pressure SensorPS11-11U252024-11-06
08594211570725ATMOS Air-Charged Pressure SensorPS11-11V052024-11-06
08594211570732ATMOS Air-Charged Pressure SensorPS11-11V252024-11-06

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