|
Physiotrace
|
Nimbleheart, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Polso Watch
|
Chronisense Medical, Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Pulse Oximeter
|
Shenzhen Creative Industry Co., Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Pulse Oximeter ( PO2, PO2A, PO2B)
|
Shenzhen Viatom Technology Co Ltd
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
|
Masimo Corp.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
REMI-AI Rapid Detection Module (REMI-AI RDM)
|
Epitel, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
REMI Remote EEG Monitoring System
|
Epitel, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
RhythmAnalytics
|
Biofourmis Singapore Pte., Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
|
Vivaquant, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Rune Labs Tremor Transducer System
|
Rune Labs, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Samsung ECG App v 1.3 (ECG)
|
Samsung Electronics Co., Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
|
Samsung Electronics Co., Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
SANSA HSAT
|
Huxley Medical
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Scan Monitor
|
Withings
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
SENSIMED TRIGGERFISH
|
SENSIMED SA
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Serenity Piezo Sensor, Serenity Thermocouple Sensor
|
Neurotronics, LLC
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Signos Glucose Monitoring System
|
Signos, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
SimplECG
|
Nanowear, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Simplera System; Simplera Sync
|
Medtronic Minimed
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
SimpleSENSE
|
Nanowear, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
SimpleSense-BP, SimpleSense-BP Software Application
|
Nanowear, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
SimpleSENSE Platform
|
Nanowear, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Sleep Apnea Feature
|
Samsung Electronics Co., Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
Sleep Apnea Notification Feature (SANF)
|
Apple, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Sleep Watch
|
AMBULATORY MONITORING, INC
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
SmartCardia 7L Platform
|
Smartcardia SA
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
SmartCardia 7L Platform (MCT)
|
Smartcardia SA
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Somfit
|
Compumedics Limited
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Somfit D
|
Compumedics Limited
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
SomnaPatch
|
Respironics, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
SomniCheck
|
Brainmatterz, LLC
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
SOMNOtouch™ RESP
SOMNOMEDICS AG
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
CA
Canada (Health Canada)
-
EU
EU (EUDAMED)
|
SOMNOMEDICS AG
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
SPEAC System
|
Brain Sentinel, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Stelo Glucose Biosensor System
|
Dexcom, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Study Watch
|
Verily Life Sciences, LLC
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Study Watch with Irregular Pulse Monitor
|
Verily Life Sciences, LLC
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
|
Verily Life Sciences, LLC
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Sunrise
|
Sunrise
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
Sunrise Sleep Disorder Diagnostic Aid
Sunrise
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
AU
AU (TGA)
-
EU
EU (EUDAMED)
|
Sunrise
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
TempTraq
|
Blue Spark Technologies, Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
TempTraq TT-100
|
Blue Spark Technologies, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
TipTraQ (TTQ001)
|
Pranaq Pte. , Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Triangle System
|
AliveCor, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
UbiqVue™ 2A Multi-parameter System (UX2550)
|
Lifesignals Inc
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Ventilator, Non-continuous (Respirator)
|
Respironics, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
VERABAND™
|
Arbor Medical Innovations, LLC
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Verily Numetric Retinal Camera
|
Verily Life Sciences, LLC
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)
|
Vitalconnect, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Vital Connect Platform, HealthPatch MD, VitalPatch
|
Vitalconnect, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
VitalConnect Platform, VitalPatch Biosensor
|
Vitalconnect, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
