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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
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 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 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 |
| True Metrix | TRUE METRIX PRE-PACK 4x24 | FDA UDI | Class II | Unknown |
| True Metrix | TRUE METRIX self monitoring blood glucose meter | FDA UDI | Class II | Unknown |
| True Metrix Pro | TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE METER FOR MULTIPLE PATIENT | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus Safety Lancets | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX Self Monitoring Blood Glucose Meter | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX Self Monitoring Blood Glucose Meter | FDA UDI | Class II | Active |
| TRUEtrack | TRUEtrack PRE-PACK | FDA UDI | Class II | Unknown |
| TRUEtrack | TRUEtrack PRE-PACK | FDA UDI | Class II | Active |
| True Metrix Air | TRUE METRIX AIR Self Monitoring Blood Glucose Meter | FDA UDI | Class II | Active |
| TRUEtrack | TRUEtrack Blood Glucose Monitoring System | FDA UDI | Class II | Unknown |
| TRUEplus | TRUEplus STERILE pen needles 31 GAUGE x 1/4" | FDA UDI | Class II | Unknown |
| True Metrix | TRUE METRIX PRE-PACK - USE ONLY FOR MEDICARE AND MEDICAID | FDA UDI | Class II | Unknown |
| TRUEplus | TRUEplus Pen Needles 31 GAUGE x 1/4" | FDA UDI | Class II | Unknown |
| True Metrix | TRUE METRIX Self Monitoring Blood Glucose Meter | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus STERILE pen needles 32 GAUGE x 5/32" | FDA UDI | Class II | Unknown |
| TRUEplus | TRUEplus 5 bevel Pen Needle 31G/6mm - 100ct box | FDA UDI | Class II | Active |
| TRUEtrack | TRUEtrack Blood Glucose Monitoring System | FDA UDI | Class II | Unknown |
| True Focus | TRUE FOCUS Self Monitoring Test Strip - 50ct | FDA UDI | Class II | Active |
| TRUEdraw | TRUEdraw Lancing Device | FDA UDI | Class II | Active |
| True Manager Air | TRUE MANAGER AIR APP - Apple iOS | FDA UDI | Class I | Active |
| True Metrix Pro | TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE METER | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus SINGLE-USE INSULIN syringes 29 gauge needle 1.0cc insulin | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 50 Test Strips | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX PRE-PACK 4x24 | FDA UDI | Class II | Unknown |
| True Metrix | TRUE METRIX PRE-PACK | FDA UDI | Class II | Unknown |
| True Metrix Air | TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METER | 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 Pen Needles 5Bevel - 31G 8mm | FDA UDI | Class II | Active |
| TRUEtrack | TRUEtrack Blood Glucose Monitoring System | FDA UDI | Class II | Unknown |
| TRUEplus | TRUEplus lancets - 30Gauge | FDA UDI | Class II | Active |
| TRUEdraw | HealthMart TRUEdraw Lancing Device | FDA UDI | Class II | Unknown |
| True Focus | TRUE FOCUS Control Solution Level 1 | FDA UDI | Class I | Active |
| True Metrix Go | TRUE METRIX GO Self Monitoring Blood Glucose Meter | FDA UDI | Class II | Unknown |
| TRUEtrack | TRUEtrack 10 Blood Glucose Test Strips | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus 3-Bevel Pen Needles 31G/8mm Tae Cha | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALE | FDA UDI | Class II | Active |
| TRUEtrack | TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | FDA UDI | Class II | Unknown |
| True Metrix Air | TRUE METRIX AIR Self Monitoring Blood Glucose Meter | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus Sterile Pen Needles | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus 3-Bevel Pen Needle 29G/12mm - 100ct box | FDA UDI | Class II | Active |
| TRUEplus | TRUEplus 5 bevel Pen Needle 31G/5mm - 100ct box | FDA UDI | Class II | Active |
| TRUEdraw | TRUEdraw Lancing Device | FDA UDI | Class II | Active |
| True Focus | TRUE FOCUS Self Monitoring Blood Glucose Meter | FDA UDI | Class I | Unknown |
| True Metrix Go | TRUE METRIX GO Self Monitoring Blood Glucose Meter | FDA UDI | Class II | Active |
| True Metrix | TRUE METRIX PRE-PACK | FDA UDI | Class II | Unknown |
| TRUEtrack | TRUEtrack PRE-PACK | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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.
| 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. |