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VitaloJAK Clinic (Model 7100)
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VITALOGRAPH INC.
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✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20
|
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)
|
|
VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
|
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)
|
|
VitalPatch® VitalConnect Platform
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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)
|
|
VitalRhythm
|
Vitalconnect, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
VitalSigns 1-Lead Holter (VSH101)
|
Vitalsigns Technology Co., Ltd.
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✓
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)
|
|
VitalWatch Software User Interface
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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)
|
|
Vitls Platform
|
Vitls, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
V-Patch Cardiac Monitor
|
Shandong Corecare Technology Limited
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
Vyvo
|
Vyvo Technology Corp.(Vt)
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Watch-PAT200U
|
Itamar 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)
|
|
WatchPAT300 (WP300)
|
Itamar 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)
|
|
WatchPAT400 (WP400)
|
Itamar 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)
|
|
WatchPAT ONE (WP1)
|
Itamar 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)
|
|
Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
|
Current Health , 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)
|
|
Wearable Device, Wearable Package
|
Current Health , Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Wesper Lab
|
Wesper, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
WesperO2
|
Wesper, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
WHOOP ECG (electrocardiogram) Feature (1.0)
|
Whoop., Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Withings ECG App
|
Withings
|
✓
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)
|
|
Withings Scan Monitor 2.0
|
Withings
|
✓
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)
|
|
Withings Sleep Rx
|
Withings
|
✓
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)
|
|
Wrist Electronic Sphygmomanometer
|
Shenzhen Changkun Technology Co., Ltd.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Wrist Type Blood Pressure Monitor
|
Xuzhou Yongkang Electronic Science Technology Co., Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
Wrist Type Blood Pressure Monitor
|
Shenzhen Jamr Medical 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)
|
|
X-trodes System M
|
X-Trodes
|
✓
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)
|
|
ZEUS System
|
iRhythm 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)
|
|
ZEUS System (Zio Watch)
|
iRhythm 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)
|
|
Zio AT® device (A100A1001)
|
iRhythm 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)
|
|
Zio AT ECG Monitoring System
|
iRhythm 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)
|
|
Zio AT ECG Monitoring System, ZEUS System
|
iRhythm 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)
|
|
Zio ECG Utilization Software (ZEUS) System
|
iRhythm 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)
|
|
Zio Monitor
|
iRhythm Technologies, Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Zio® monitor (DFG0001)
|
iRhythm 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)
|
|
ZIO SR ECG Monitoring Service
|
iRhythm 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)
|
|
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
|
iRhythm 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)
|
