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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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ACTIVE HANDGRIP FOR KP G3
Alpine Biomed ApS
9031E0153
Not in Commercial Distribution

  • 05704736002363 ()


  • Electromyograph
2-channel EMG/EP Amplifier with 1.7 m cable
Alpine Biomed ApS
9031C0503
Not in Commercial Distribution

  • 05704736002288 ()


  • Electromyograph
KEYPOINT WORKSTATION IT
Alpine Biomed ApS
9031A006506
Not in Commercial Distribution

  • 05704736001861 ()


  • Electromyograph
KEYPOINT WORKSTATION NL
Alpine Biomed ApS
9031A006505
Not in Commercial Distribution

  • 05704736001854 ()


  • Electromyograph
KEYPOINT WS SPXP-OS
Alpine Biomed ApS
9031A006504
Not in Commercial Distribution

  • 05704736001847 ()


  • Electromyograph
KEYPOINT WORKSTATION GE
Alpine Biomed ApS
9031A006503
Not in Commercial Distribution

  • 05704736001830 ()


  • Electromyograph
KEYPOINT WORKSTATION FR
Alpine Biomed ApS
9031A006502
Not in Commercial Distribution

  • 05704736001823 ()


  • Electromyograph
KEYPOINT WORKSTATION INT. 115 VOLT,US VER.W/O US SOFT.
Alpine Biomed ApS
9031A0065HA
Not in Commercial Distribution

  • 05704736001809 ()


  • Electromyograph
KEYPOINT WS USXP-OS
Alpine Biomed ApS
9031A0065AA
Not in Commercial Distribution

  • 05704736001793 ()


  • Electromyograph
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
ACTIVE HANDGRIP FOR KP G3
Alpine Biomed ApS
9031E0153
Not in Commercial Distribution

  • 00673978212043 ()


  • Electromyograph
4 CH. AMP BOX/ARM KEYPOINT
Alpine Biomed ApS
9031C0312
Not in Commercial Distribution

  • 00673978206998 ()


  • Electromyograph
2 CHANNEL EMG/EP AMPLI-
Alpine Biomed ApS
9031C0302
Not in Commercial Distribution

  • 00673978206981 ()


  • Electromyograph
The SX230FW EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. The EMG Amplifier (SX230FW) uses disposable electrodes and has a variable electrode distance. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Metal connector
BIOMETRICS LIMITED
SX230FW
In Commercial Distribution

  • 05060481691512 ()
bandwidth 20-460 metal connector

  • Electromyograph
The SX230-100 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230-100 EMG Sensor (Gain 100, Bandwidth 20-460Hz) - Metal connector
BIOMETRICS LIMITED
SX230-100
In Commercial Distribution

  • 05060481691505 ()
Gain 100, bandwidth 20-460 metal connector

  • Electromyograph
The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230-1000 EMG Sensor (Gain 1000, Bandwidth 5-1000Hz) - Metal connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691499 ()
bandwidth 5-1000 metalconnector

  • Electromyograph
The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm..This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230-1000 EMG Sensor (Gain 1000, Bandwidth 5-480Hz) - Metal connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691482 ()
bandwidth 5-480 metal connector

  • Electromyograph
The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 SX230-1000 EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Metal connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691475 ()
bandwidth 20-460 metal connector

  • Electromyograph
The SX230FW EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. The EMG Amplifier (SX230FW) uses disposable electrodes and has a variable electrode distance. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Plastic connector
BIOMETRICS LIMITED
SX230FW
In Commercial Distribution

  • 05060481691468 ()
bandwidth 20-460 plastic connector

  • Electromyograph
The SX230-100 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230-100 EMG Sensor (Gain 100, Bandwidth 20-460Hz) - Plastic connector
BIOMETRICS LIMITED
SX230-100
In Commercial Distribution

  • 05060481691451 ()
Gain 100, bandwidth 20-460 plastic connector

  • Electromyograph
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