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Sign in to claim this brandHearts Bio, Inc.
US
Last updated May 23, 2026
What Hearts Bio, Inc. makes
Hearts Bio, Inc. makes in vitro diagnostic devices for measuring biomarkers in blood, including lactate, total cholesterol, uric acid, and glucose. Their products consist of reagent test strips and kits designed for use with handheld monitoring systems, such as the HeartsCare C1 and C1 Plus models, which support electrometric measurement of glucose and other analytes.
These devices are classified as Class I and Class II medical devices and are listed in the FDA’s Unique Device Identification (fda_udi) system. 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 medical devices does Hearts Bio, Inc. produce?
Hearts Bio, Inc. manufactures in vitro diagnostic devices for measuring biomarkers in blood, including lactate, total cholesterol, uric acid, and glucose. Their products consist of reagent test strips and kits designed for use with handheld monitoring systems like the HeartsCare C1 and C1 Plus models.
Where is Hearts Bio, Inc. based?
Hearts Bio, Inc. is based in the United States, as indicated by the country designation in their device data.
Which regulatory registries list Hearts Bio, Inc.'s devices?
Hearts Bio, Inc.'s devices are listed in the FDA's Unique Device Identification (fda_udi) system, which is the only registry mentioned in their device data.
How are Hearts Bio, Inc.'s medical devices classified?
Hearts Bio, Inc.'s devices are classified as Class I and Class II medical devices, with Class I being lower risk and Class II requiring more regulatory controls, as specified in their device data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 085509873
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HeartsCare BLOOD GLUCOSE TEST STRIPS (50PCS/BOX) | TD-4289 | FDA UDI | Class II | Active |
| HeartsCare LACTATE TEST STRIPS (10PCS/BOX) | TD-4289 | FDA UDI | Class I | Active |
| HeartsCare LACTATE TEST STRIPS (25PCS/BOX) | TD-4289 | FDA UDI | Class I | Active |
| HeartsCare C1 monitoring system | TD-4289 | FDA UDI | Class I | Active |
| HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX) | TD-4289 | FDA UDI | Class I | Active |
| HeartsCare C1 Total Cholesterol Test Strip (10pcs/box) | TD-4289 | FDA UDI | Class I | Active |
| HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX) | TD-4289 | FDA UDI | Class I | Active |
| HeartsCare C1 Plus Multi-Functional Monitoring System | TD-4289 | FDA UDI | Class II | Active |
| HeartsCare C1 Plus Multi-Functional Monitoring System | TD-4289 | FDA UDI | Class II | Active |
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