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Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital monitors intended for use in measuring blood pressure. The device can be used to detect irregular heartbeat. It is intended for adult indoor use only FDA UDI
- Model / Reference
- 1168-05 FDA UDI
- Description
- The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital monitors intended for use in measuring blood pressure. The device can be used to detect irregular heartbeat. It is intended for adult indoor use only FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850033352009 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System by Dariohealth Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automatic-inflation electronic sphygmomanometer, portable, arm/wrist.
- Arm Type Automatic Blood Pressure Monitor — Shenzhen Jiacom Technology Co., Ltd · Class II
- MoDash — Shenzhen Urion Technology Co., Ltd. · Class II
- Veridian Healthcare — VERIDIAN HEALTHCARE · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- BRIGHT LIFE — Shenzhen Urion Technology Co., Ltd. · Class II
- RemoteCare 4U — Guangdong Transtek Medical Electronics Co., Ltd · Class II
- Omron 3 Series Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc. · Class II
- NURSAL — Shenzhen Jamr Medical Technology Co., Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dariohealth Corp.
Sources (1)
- FDA UDI a93b384a-5fcc-4293-b3a2-fcd50ac5f019 33 fields · synced Jun 1, 2026