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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Uroval - 00852523007062

The Uroval BRS System is used to record and display electromyogram (EMG )signals. In addition, the BRS System will determine latency time intervals of the bulbocavernosus reflex (BCR). The Uroval BRS System also has report generation capabilities. The Uroval BRS System uses a probe, with a single use disposable tip to evoke a BCR response and activate recording and timing of EMG signals. The Uroval BRS System uses pre-gelled surface electrodes to monitor the muscle activity.
UROVAL, INC.
BRS System
In Commercial Distribution

  • 00852523007062 ()
BRS01

  • Electromyograph

Alpine BioMed - 00721902428531

EP HEADBOX UNIT
Alpine Biomed ApS
8031C0551
Not in Commercial Distribution

  • 00721902428531 ()


  • Electromyograph

Alpine BioMed - 00721902428524

8 CH. AMPLIFIER
Alpine Biomed ApS
8031C0521
Not in Commercial Distribution

  • 00721902428524 ()


  • Electromyograph

Alpine BioMed - 00721902428517

4 CH. AMPLIFIER
Alpine Biomed ApS
8031C0511
Not in Commercial Distribution

  • 00721902428517 ()


  • Electromyograph

Alpine BioMed - 00721902428500

2 CH. AMPLIFIER
Alpine Biomed ApS
8031C0501
Not in Commercial Distribution

  • 00721902428500 ()


  • Electromyograph

PillSense Receiver - 05391539210073

The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule. The PillSense Receiver interprets the data and displays a result message “Blood Detected” or “No Blood Detected”.
ENTERASENSE LIMITED
P00167-01FP
In Commercial Distribution

  • 05391539210073 ()


  • Gastrointestinal telemetric monitoring system receiver

Alpine BioMed - 05704736019149

KP Focus Notebook, UK 230V special for China
Alpine Biomed ApS
9033A0711CN
Not in Commercial Distribution

  • 05704736019149 ()


  • Electromyograph

Alpine BioMed - 05704736019064

FRONT END BOX, KEYPOINT G4
Alpine Biomed ApS
9031G0703
Not in Commercial Distribution

  • 05704736019064 ()


  • Electromyograph

Alpine BioMed - 05704736019026

FOCUS MAIN UNIT
Alpine Biomed ApS
9033G0703
Not in Commercial Distribution

  • 05704736019026 ()


  • Electromyograph

Alpine BioMed - 05704736018418

6-ch. EP Amplifier
Alpine Biomed ApS
9031C0771
Not in Commercial Distribution

  • 05704736018418 ()


  • Electromyograph
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