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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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PARO Robot - 04580537541222

A baby seal type robot with artificial intelligence in Gold Color Neurological Therapeutic Medical Device Biofeedback Medical Device For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc
INTELLIGENT SYSTEM CO.,LTD.
MCR-900 UC Gold
In Commercial Distribution

  • 04580537541222 ()
V9-14UC

  • Psychophysiological biofeedback system

PARO Robot - 04580537541215

A baby seal type robot with artificial intelligence Neurological Therapeutic Medical Device Biofeedback Medical Device For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc
INTELLIGENT SYSTEM CO.,LTD.
MCR-900 UC White
In Commercial Distribution

  • 04580537541215 ()
V9-14UC

  • Psychophysiological biofeedback system

EXSYS DEXi - 08800018425909

No Description
DRTECH Corporation
EXSYS DEXi-D503T-FRA
In Commercial Distribution

  • 08800018425909 ()


  • Stationary basic diagnostic x-ray system, digital

EXSYS DEXi - 08800018425800

No Description
DRTECH Corporation
EXSYS DEXi-D402P-FRA
In Commercial Distribution

  • 08800018425800 ()


  • Stationary basic diagnostic x-ray system, digital

EXSYS DEXi - 08800018425701

No Description
DRTECH Corporation
EXSYS DEXi-D401P-FRA
In Commercial Distribution

  • 08800018425701 ()


  • Stationary basic diagnostic x-ray system, digital

EXSYS DEXi - 08800018425602

No Description
DRTECH Corporation
EXSYS DEXi-D402S-FRA
In Commercial Distribution

  • 08800018425602 ()


  • Stationary basic diagnostic x-ray system, digital

EXSYS DEXi - 08800018425503

No Description
DRTECH Corporation
EXSYS DEXi-D401S-FRA
In Commercial Distribution

  • 08800018425503 ()


  • Stationary basic diagnostic x-ray system, digital

EXSYS DEXi - 08800018422403

No Description
DRTECH Corporation
EXSYS DEXi-A503T-FRM
In Commercial Distribution

  • 08800018422403 ()


  • Stationary basic diagnostic x-ray system, digital

EXSYS DEXi - 08800018422304

No Description
DRTECH Corporation
EXSYS DEXi-A402P-FRM
In Commercial Distribution

  • 08800018422304 ()


  • Stationary basic diagnostic x-ray system, digital

EXSYS DEXi - 08800018422205

No Description
DRTECH Corporation
EXSYS DEXi-A401P-FRM
In Commercial Distribution

  • 08800018422205 ()


  • Stationary basic diagnostic x-ray system, digital
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