Omron Healthcare, Inc.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• omron.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Omron Model BP7900 Blood Pressure Monitor + EKG

  2021-04-01

  Omron Healthcare, Inc.

• Focus TENS Therapy, Model PM710-M/-L

  2019-09-07

  Omron Healthcare, Inc.

• HEM-6410T-ZL Wrist Blood Pressure Monitor

  2019-04-17

  Omron Healthcare, Inc.

• Omron Model BP7900 Blood Pressure Monitor + EKG

  2019-03-14

  Omron Healthcare, Inc.

• Maxpower Relief

  2019-01-10

  Omron Healthcare, Inc.

• HEM-6410T-ZM Wrist Blood Pressure Monitor

  2018-11-09

  Omron Healthcare, Inc.

• Heat Pain Pro

  2018-11-09

  Omron Healthcare, Inc.

• Wrist Blood Pressure Monitor Model BP4350

  2018-11-08

  Omron Healthcare, Inc.

• Wrist Blood Pressure Monitor Model BP6100

  2018-11-02

  Omron Healthcare, Inc.

• Avail

  2017-10-19

  Omron Healthcare, Inc.

• HEM-9210T

  2017-04-20

  Omron Healthcare, Inc.

• Omron HEM-6400T-Z Wrist Blood Pressure Monitor

  2017-02-21

  Omron Healthcare, Inc.

• Evolv Model BP7000 Upper Arm Blood Pressure Monitor

  2016-11-22

  OMRON HEALTHCARE, INC.

• Heat Pain Pro

  2016-06-03

  OMRON HEALTHCARE, INC.

• MAXPOWER RELIEF

  2014-12-03

  OMRON HEALTHCARE, INC.

• BP652N (HEM-6300-Z)

  2014-12-01

  OMRON Healthcare, Inc

• COMP A-I-R

  2014-09-30

  OMRON HEALTHCARE, INC.

• HEM-7320

  2014-03-04

  OMRON HEALTHCARE, INC.

• HEM-7311

  2014-01-16

  OMRON HEALTHCARE, INC.

• HEM-6221

  2013-10-07

  OMRON HEALTHCARE, INC.

• HEM-6131

  2013-07-24

  OMRON HEALTHCARE, INC.

• BP652N (HEM-6300-Z)

  2013-03-21

  OMRON HEALTHCARE, INC.

• HEM-7200-Z (BP742)

  2012-08-29

  OMRON HEALTHCARE, INC.

• LONG LIFE PADTM

  2012-05-17

  OMRON HEALTHCARE, INC.

• MODEL HBP-1300

  2012-01-27

  OMRON HEALTHCARE, INC.

• MODEL PM3030

  2011-12-08

  OMRON HEALTHCARE, INC.

• COMP A-I-R

  2011-09-02

  OMRON HEALTHCARE, INC.

• HEM-4030

  2011-03-21

  OMRON HEALTHCARE, INC.

• MC-245, MC-246, MC-247, MC-341, MC-343, MC-344

  2009-09-01

  OMRON HEALTHCARE, INC.

• OMRON MODEL HBP-2070 VITAL SIGNS MONITOR

  2008-10-22

  OMRON HEALTHCARE, INC.

• HEM-9000AI

  2008-10-10

  OMRON HEALTHCARE, INC.

• 1500 PRO

  2008-02-26

  OMRON HEALTHCARE, INC.

• MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S

  2007-07-02

  OMRON HEALTHCARE, INC.

• COLIN PRESS MATE, MODEL BP S510

  2007-05-09

  OMRON HEALTHCARE, INC.

• OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22

  2007-02-23

  OMRON HEALTHCARE, INC.

• BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500

  2006-11-07

  OMRON HEALTHCARE, INC.

• OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3

  2006-08-02

  OMRON HEALTHCARE, INC.

• PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801

  2006-06-09

  OMRON HEALTHCARE, INC.

• OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30

  2006-05-25

  OMRON HEALTHCARE, INC.

• OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI

  2005-10-28

  OMRON HEALTHCARE, INC.

65 records. Showing 1-40. Next

GUDID#

• WIDE-RANGE D-RING CUFF - The HEM-RML31-C is a reusable Wide-Range D-Ring Cuff accessory intended for use with compatible OMRON blood pressure monitors. The cuff is designed for users with an upper arm circumference of 9 to 17 inches (22 to 42 cm). The cuff consists of a fabric cuff, inflatable bladder, air tube, and air plug. During use, the cuff is wrapped around the upper arm and connected to the blood pressure monitor through the air plug. When a measurement is initiated, the monitor inflates and deflates the cuff to temporarily occlude and then releases the brachial artery. The cuff transfers the pressure changes generated during the measurement process to the monitor, which performs the blood pressure and pulse rate calculations. The HEM-RML31-C is a non-powered accessory and contains no electronics, software, wireless communication functions, or user configurable settings.

  Omron Healthcare, Inc.

  2026-07-20

• SMALL D-RING CUFF - The HEM-CS24-C is a reusable Small D-Ring upper-arm cuff accessory intended for use with compatible OMRON blood pressure monitors. The cuff is designed for users with an upper arm circumference of 7 to 9 inches (17 to 22 cm). The cuff consists of a fabric cuff, inflatable bladder, air tube, and air plug. During use, the cuff is wrapped around the upper arm and connected to the blood pressure monitor through the air plug. When a measurement is initiated, the monitor inflates and deflates the cuff to temporarily occlude and then release the brachial artery. The cuff transfers the pressure changes generated during the measurement process to the monitor, which performs the blood pressure and pulse rate calculations. The HEM-CS24-C is a non-powered accessory and contains no electronics, software, wireless communication functions, or user-configurable settings.

  Omron Healthcare, Inc.

  2026-07-20

• VIVA 360+ Smart Scale - VIVA 360+ Smart Scale is intended to be used to calculate and display the estimated value of body fat percentage, subcutaneous fat percentage, skeletal muscle percentage, resting metabolism, body water percentage, bone mass, fat free mass and visceral fat levels using the BI (Bioelectrical Impedance) method and indicates the BMI (Body Mass Index). The VIVA 360+ Smart Scale is intended to be used by healthy individuals in the age range of 18 to 80 years for the subcutaneous fat percentage and visceral fat level. The age range for body fat percentage, skeletal muscle percentage, resting metabolism, body water percentage, bone mass and fat free mass are intended to be used by healthy individuals between the age of 6 to 80 years. The device is intended for multiple-patient, multiple-use

  Omron Healthcare, Inc.

  2026-06-16

• Silver, Upper Arm Blood Pressure Monitor - The Omron Upper Arm Blood Pressure Monitor is an OTC, at home use, upper arm blood pressure monitor. The device consists of a monitor and an arm cuff designed to be used on the upper arm. It is battery powered and can optionally be connected to an AC adapter. The proposed device measures blood pressure (systolic [SYS] and diastolic [DIA]) and pulse rate (PR), detects the presence of irregular heartbeats, and can also detect the possible presence of AFib by analyzing pulse pressure wave data captured during the user's blood pressure measurement to identify episodes of AFib and provides a notification on the display screen to the user. Additionally, the Monitor may be used with the Omron Connect mobile application ("App"), an optional software-only accessory residing on a consumer smart device which connects to the device via Bluetooth Low Energy (BLE) and transfers information on completed device recordings for storage and redisplay. When the measurement is complete, if atrial fibrillation has not been detected in the reading, and the time/date appear alternately. If atrial fibrillation is detected in the reading, the device displays the "Possible AFib" icon and furthermore, displays the characters "AF" in place of blood pressure readings. No blood pressure or pulse rate readings are displayed to the user

  Omron Healthcare, Inc.

  2026-05-26

• Omron MicroAir Vibrating Mesh Nebulizer - Portable vibrating mesh nebulizer

  Omron Healthcare, Inc.

  2018-10-22

• Omron CompAir Compressor Nebulizer - Omron compressor nebulizer, with nebulizer kit and pediatric mask.

  Omron Healthcare, Inc.

  2020-08-03

• Omron Micro Air Vibrating Mesh Nebulizer - Micro Air Vibrating Mesh Nebulizer

  Omron Healthcare, Inc.

  2017-05-17

• Omron CompAir Elite Compact Compressor Nebulizer - CompAir Elite Compact Compressor Nebulizer

  Omron Healthcare, Inc.

  2017-05-17

• Omron CompAir Compressor Nebulizer - Compressor Nebulizer

  Omron Healthcare, Inc.

  2017-05-17

• Omron CompAir Mini-Nebulizer - CompAir Mini-Nebulizer

  Omron Healthcare, Inc.

  2017-05-17

• Upper Arm Blood Pressure Monitor - Omron Upper Arm Blood Pressure Monitor with Bluetooth smart connectivity. 100 memory storage for one user. One piece design.

  Omron Healthcare, Inc.

  2025-07-15

• Upper Arm Blood Pressure Monitor - Omron Upper Arm Blood Pressure Monitor with Bluetooth smart connectivity. 100 memory storage for one user. One piece design.

  Omron Healthcare, Inc.

  2025-07-15

• Blood Pressure Monitor - Upper Arm Blood Pressure Monitor with Possible AFib Detection Feature, 60 memory per user, 2 user total, Automatic Inflation, AC Adapter, Hypertension Indicator

  Omron Healthcare, Inc.

  2025-06-27

• Blood Pressure Monitor - Upper Arm Blood Pressure Monitor with Possible AFib Detection Feature, 60 memory per user, 2 user total, Automatic Inflation, AC Adapter, Hypertension Indicator

  Omron Healthcare, Inc.

  2025-06-27

• Omron Small D-ring Cuff - "Optional Cuff (7"" to 9"") for Omron Digital Blood Pressure Monitor"

  Omron Healthcare, Inc.

  2019-04-03

• Omron 5 Series Upper Arm Blood Pressure Monitor - 5 Series upper arm blood pressure monitor with Bluetooth, 60 memory and wide range cuff.

  Omron Healthcare, Inc.

  2019-07-08

• Omron 7 Series Upper Arm Blood Pressure Monitor - 7 Series upper arm blood pressure monitor with Bluetooth, 120 memory, and 2 users.

  Omron Healthcare, Inc.

  2019-07-08

• Omron 10 Series Upper Arm Blood Pressure Monitor - 10 Series upper arm blood pressure monitor with Bluetooth, 200 memory, 2 users and TruRead technology

  Omron Healthcare, Inc.

  2019-07-08

• Blood Pressure Monitor - Telehealth Blood Pressure Monitor with extra large cuff compatibility.

  Omron Healthcare, Inc.

  2022-07-01

• Omron Blood Pressure Monitor - Blood Pressure Monitor w/Bluetooth, Comparison Display, pre-formed Comfit Cuff, irregular heartbeat detector and 200 memory storage.

  Omron Healthcare, Inc.

  2021-09-01

• Omron 3 Series Upper Arm Blood Pressure Monitor - 3 Series upper arm blood pressure monitor with 14 memory storage and wide range cuff. Easy one-touch operation.

  Omron Healthcare, Inc.

  2019-07-08

• AC Adapter for digital Blood Pressure Units - AC Adapter

  Omron Healthcare, Inc.

  2016-09-16

• AC Adapter for HEM-907XL - AC Adapter for HEM-907XL, Digital Blood Pressure Monitor

  Omron Healthcare, Inc.

  2016-09-16

• AC Adapter for NE-C30 - C30AC

  Omron Healthcare, Inc.

  2016-09-16

• Omron Air Filters for NE-C30 - Air Filters for NE-C30 Nebulizer

  Omron Healthcare, Inc.

  2017-05-17

• "Wide Range D-Ring Cuff 9"" to 17""" - "Contoured wide range Blood Pressure Cuff 9"" to 17"""

  Omron Healthcare, Inc.

  2016-09-16

• "Countoured Small Arm Cuff 7""-9""" - Contoured Small Arm Blood Pressure Cuff

  Omron Healthcare, Inc.

  2016-09-16

• "Easy Wrap Comfit Cuff 9""-17""" - "Easy Wrap Comfit Blood Pressure Cuff 9"" to 17"""

  Omron Healthcare, Inc.

  2016-09-16

• Omron Nebulizer Kit with Air Tube and Mouthpiece - Nebulizer Kit with Air Tube and Mouthpiece

  Omron Healthcare, Inc.

  2017-05-17

• Omron Mouthpiece for Nebulizer - Mouthpiece for Use with Nebulizer Kit

  Omron Healthcare, Inc.

  2017-05-17

• Omron Nosepiece for Nebulizer - Nosepiece for Nebulizer Kit

  Omron Healthcare, Inc.

  2017-05-17

• Omron Mouthpiece for Vibrating Mesh Nebulizer - Mouthpiece for Vibrating Mesh Nebulizer NE-U22V

  Omron Healthcare, Inc.

  2017-05-17

• Omron Mask and Mouthpiece Adapter - Mask and Mouthpiece Adapter for Vibrating Mesh Nebulizer NE-U22V

  Omron Healthcare, Inc.

  2017-05-17

• Omron Mesh Cap for Nebulizer - Mesh Cap for Vibrating Mesh Nebulizer NE-U22V

  Omron Healthcare, Inc.

  2017-05-17

• AC Adapter for Vibrating Mesh Nubulizer NE-U22V - AC Adapter for Omron Vibrating Mesh Nebulizer NE-U22V

  Omron Healthcare, Inc.

  2016-09-16

• Omron Nebulizer Kit with Air Tube and Mouthpiece - Nebulizer Kit with Air Tube and Mouthpiece for NE-C801

  Omron Healthcare, Inc.

  2017-05-17

• AC Adapter for NE-C803 - C803AC

  Omron Healthcare, Inc.

  2016-09-16

• Omron Nebulizer Kit - Nebulizer Kit for NE-C803

  Omron Healthcare, Inc.

  2017-05-17

• Small Cuff, Bladder for Hem-907 - Blood Pressure Cuff and Bladder for HEM-907 (Small)

  Omron Healthcare, Inc.

  2016-09-16

• Medium Cuff, Bladder for HEM-907 - Blood Pressure Cuff and Bladder for HEM-907 (Medium)

  Omron Healthcare, Inc.

  2016-09-16

200 records. Showing 1-40. Next