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Sign in to claim this brandTRIVIDIA HEALTH, INC.
US
Last updated September 17, 2026
About
We are the leading developer, manufacturer and marketer of advanced performance products for people living with diabetes.
From the manufacturer's own website. Source
What TRIVIDIA HEALTH, INC. makes
The company manufactures in vitro diagnostic (IVD) glucose monitoring systems for home use, including reusable blood lancing devices and disposable lancing device tips, as well as insulin syringes and needles. It also produces autoinjector needles, glucose control solutions, and software for self-care monitoring and reporting. Electrical connection cables for medical devices are part of the portfolio.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) and UDI registries. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Trividia Health, Inc. manufacture?
Trividia Health, Inc. specializes in devices primarily for diabetes management. These include home-use in vitro diagnostic (IVD) glucose monitoring systems, reusable and disposable blood lancing devices (like tips and manual lancers), insulin syringes and needles, autoinjector needles, glucose control solutions, and self-care monitoring software. The company also produces reusable electrical connection cables for medical devices, which help facilitate safe device-to-device communication.
Where is Trividia Health, Inc. based, and how does that affect its regulatory standing?
Trividia Health, Inc. is based in the United States, which means its devices are subject to FDA regulations. The company’s products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, indicating they have undergone the necessary premarket submissions required for commercial distribution in the U.S. However, regulatory clearance or approval applies to individual devices, not the company itself.
Which regulatory registries list Trividia Health, Inc.’s devices, and why does this matter?
Trividia Health, Inc.’s devices are recorded in the FDA’s 510(k) and UDI registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures accurate identification and traceability of medical devices throughout their lifecycle. Listing in these registries helps healthcare providers, regulators, and patients verify the device’s regulatory history and compliance status.
How are Trividia Health, Inc.’s devices classified under FDA regulations, and what does that mean?
Trividia Health, Inc.’s devices fall into Class I and Class II classifications under FDA regulations. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional premarket notification (510(k)) because they carry a higher risk. The classification determines the level of scrutiny and regulatory oversight required, ensuring appropriate safety and performance standards are met before commercialization.
What kinds of software products does Trividia Health, Inc. develop, and how do they fit into its portfolio?
Trividia Health, Inc. develops self-care monitoring and reporting software, which helps users track and manage diabetes-related metrics like glucose levels. These digital tools complement its hardware devices (like glucose monitors and lancers) by enabling data aggregation, trend analysis, and reporting—supporting better patient engagement and clinical decision-making. Since software in healthcare often interacts with medical devices, it may also be subject to FDA oversight as part of a broader system.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 2400 NW 55TH CT, Fort Lauderdale, FL, 33309
- Website
- www.trividiahealth.com
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000113657
- DUNS Number
- —
Catalogue (238)
Page 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TRUEtrack | TRUEtrack Blood Glucose Meter - Free Meter Only | FDA UDI | Class II | Unknown |
| TRUEplus | TRUEplus Pen Needles 29 GAUGE x 1/2" | FDA UDI | Class II | Unknown |
| TRUEplus | CVS TRUEplus Lancets - 33G | FDA UDI | Class II | Active |
| TRUEplus | Good Neighbor Pharmacy TRUEplus Sterile Lancets | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX Self Monitoring Blood Glucose Meter | FDA UDI | Class II | Unknown |
| My-TECH | My-TECH Self Monitoring Blood Glucose Test Strips | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - FREE METER ONLY | FDA UDI | Class II | Active |
| TRUEplus | Sunmark TRUEplus Sterile Lancets | FDA UDI | Class II | Unknown |
| True Metrix | TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER | FDA UDI | Class II | Unknown |
| TRUEplus | TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 1.0cc insulin | FDA UDI | Class II | Active |
| True Metrix Air | TRUE METRIX AIR self monitoring blood glucose meter | FDA UDI | Class II | Active |
| TRUEdraw | Good Neighbor Lancing Device | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus Pen Needles 5Bevel - 31G 8mm - 50ct box | FDA UDI | Class II | Active |
| True Focus | TRUE FOCUS Control Solution Level 3 | FDA UDI | Class I | Active |
| TRUEplus | TopCare TRUEplus Sterile Lancets | FDA UDI | Class II | Active |
| TRUEplus | HealthMart TRUEplus Sterile Lancets | FDA UDI | Class II | Unknown |
| True Metrix Air | TRUE METRIX AIR Self Monitoring Blood Glucose Meter | FDA UDI | Class II | Active |
| TRUEdraw | Rite Aid TRUEdraw Lancing Device | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER | FDA UDI | Class II | Active |
| True Metrix Pro | TRUE METRIX PRO BLOOD GLUCOSE TEST STRIPS - 50 Test Strips | FDA UDI | Class II | Active |
| TRUEdraw | CVS TRUEdraw Lancing Device | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX Control Solution Level 3 | FDA UDI | Class I | Active |
| True Metrix | TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 30 Test Strips | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX PRE-PACK 4x24 | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX PRE-PACK 4x24 | FDA UDI | Class II | Unknown |
| TRUEplus | CVS TRUEplus Lancets | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus 5-bevel Pen Needle 31G/8mm - 100ct box | FDA UDI | Class II | Unknown |
| True Metrix | TRUE METRIX self monitoring blood glucose meter | FDA UDI | Class II | Unknown |
| True Metrix | TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER | FDA UDI | Class II | Unknown |
| TRUEplus | TRUEplus STERILE pen needles 31 GAUGE x 3/16" | FDA UDI | Class II | Unknown |
| True Metrix | TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - FREE METER ONLY | FDA UDI | Class II | Unknown |
| True Metrix | TRUE METRIX self monitoring blood glucose meter | FDA UDI | Class II | Active |
| TRUEtrack | TRUEtrack BLOOD GLUCOSE METER | FDA UDI | Class II | Active |
| TRUEplus | HealthMart TRUEplus Sterile Lancets | FDA UDI | Class II | Unknown |
| True Metrix | TRUE METRIX Self Monitoring Blood Glucose Test Strips | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus Sterile Lancets | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX Self-Monitoring Blood Glucose Meter | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus STERILE pen needles 31 GAUGE x 5/16" | FDA UDI | Class II | Active |
| TRUEdraw | Sunmark TRUEdraw Lancing Device | FDA UDI | Class II | Unknown |
| Sidekick | Sidekick All-In-One Blood Glucose Monitoring System | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus 5-bevel Pen Needle 32G/4mm - 100ct box | FDA UDI | Class II | Unknown |
| True Metrix Air | TRUE METRIX AIR self monitoring blood glucose meter | FDA UDI | Class II | Unknown |
| TRUEplus | TRUEplus Pen Needles - 5 Bevel | FDA UDI | Class II | Active |
| True Focus | TRUE FOCUS Control Solution Level 2 | FDA UDI | Class I | Active |
| TRUEtrack | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | FDA UDI | Class II | Unknown |
| True Metrix | TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER | FDA UDI | Class II | Active |
| Trueness | TRUENESS Blood Glucose Test Strips | FDA UDI | Class II | Active |
| TRUEtrack | TRUEtrack PRE-PACK | FDA UDI | Class II | Unknown |
| TRUEplus | TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 0.3cc insulin | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus SINGLE-USE INSULIN syringes 28 gauge needle 0.5cc insulin | FDA UDI | Class II | Active |
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FDA Recalls (10)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Trividia Health, Inc. has ten FDA recall records initiated between June 28, 2016, and February 6, 2026. The records include open, classified, and terminated statuses, with reasons involving manufacturing defects—such as LCD display malfunctions causing misread glucose values, incorrect unit settings (mmol/L instead of mg/dL), and inaccurate low-glucose readings—as well as labeling deficiencies related to error code instructions for users.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 6, 2026 | Z-1545-2026 | — | open, classified | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. |
| Feb 6, 2026 | Z-1547-2026 | — | open, classified | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. |
| Feb 6, 2026 | Z-1548-2026 | — | open, classified | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. |
| Feb 6, 2026 | Z-1546-2026 | — | open, classified | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. |
| Oct 7, 2025 | Z-0413-2026 | — | open, classified | Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management. |
| Apr 20, 2020 | Z-2201-2020 | — | terminated | One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX blood glucose meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL. |
| Jun 28, 2016 | Z-2881-2016 | — | open, classified | Product gives incorrect low blood glucose levels. |
| Jun 28, 2016 | Z-2880-2016 | — | open, classified | Product gives incorrect low blood glucose levels. |
| Jun 28, 2016 | Z-2882-2016 | — | open, classified | Product gives incorrect low blood glucose levels. |
| Jun 28, 2016 | Z-2883-2016 | — | open, classified | Product gives incorrect low blood glucose levels. |