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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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EpiMonitor - 00853858006386

No Description
EMPATICA SRL
EpiMonitor App Android
In Commercial Distribution

  • 00853858006386 ()


  • Home seizure monitoring system

myBETAapp - 05713495000060

No Description
Phillips-Medisize A/S
Android (Mobile App)
Not in Commercial Distribution

  • 05713495000060 ()
84601063

  • Medication reminder application software

actiTENS - B786SBM2AA1100

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS Android app
In Commercial Distribution

  • B786SBM2AA1100 ()
SBM2AA110

  • Analgesic transcutaneous electrical nerve stimulation system

Philips - 05714464059775

PHILIPS HEARLINK CONNECT 3.5.0 ANDROID
Sbo Hearing A/S
246111
In Commercial Distribution

  • 05714464059775 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464059737

BERNAFON EASYCONTROL CONNECT 3.5.0 ANDROID
Sbo Hearing A/S
246107
In Commercial Distribution

  • 05714464059737 ()


  • Hearing aid/implant system remote control

Philips - 05714464058983

Philips HearLink 2 1.0.0 Android
Sbo Hearing A/S
242487
In Commercial Distribution

  • 05714464058983 ()


  • Hearing aid/implant system remote control

Sonic - 05714464059751

SONIC SOUNDLINK CONNECT 3.5.0 ANDROID
Sbo Hearing A/S
246109
In Commercial Distribution

  • 05714464059751 ()


  • Hearing aid/implant system remote control

Philips - 05714464146079

PHILIPS HEARLINK 2 1.5.0 ANDROID
Sbo Hearing A/S
274916
In Commercial Distribution

  • 05714464146079 ()


  • Hearing aid/implant system remote control

Philips - 05714464139514

PHILIPS HEARLINK 2 1.4.0 ANDROID
Sbo Hearing A/S
270497
In Commercial Distribution

  • 05714464139514 ()


  • Hearing aid/implant system remote control

Sonic - 05714464127184

SONIC SOUNDLINK 3 1.2.0 ANDROID
Sbo Hearing A/S
265709
In Commercial Distribution

  • 05714464127184 ()


  • Hearing aid/implant system remote control
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