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Sign in to claim this brandCoaguSense Inc.
United States·US-MF-000026989
Last updated May 30, 2026
What CoaguSense Inc. makes
CoaguSense Inc. manufactures in vitro diagnostic (IVD) devices focused on prothrombin time (PT) testing, including rapid clotting assays and monitoring systems for clinical and patient self-testing. Their portfolio includes test strips, control kits, and handheld meters designed to measure PT and international normalized ratio (INR) levels, primarily for anticoagulation management.
The company’s devices are classified under Class II (IVD General) and are listed in regulatory databases such as EUDAMED, FDA’s 510(k) clearance records, and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 48377, Fremont Blvd., Fremont, United States
- Website
- www.coag-sense.com
- —
- —
- [email protected]
- Phone
- +1 510-892-2379
- PRRC Contact
- Mike Acosta
- EUDAMED SRN
- US-MF-000026989
- FDA FEI Number
- —
- DUNS Number
- 007943352
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Assure PT Care PT/INR Monitoring System | 350222 | FDA UDI | Class II | Active |
| Coag-sense | 03F73-05 | FDA UDI | Class II | Active |
| Assure PT Care Test Strip Kit | 350218 | FDA UDI | Class II | Active |
| Coag-Sense PT/INR Meter | 200107 | FDA UDI | Class II | Active |
| Coag-Sense PT/INR Patient Self-Test System | 200221 | FDA UDI | Class II | Active |
| Coag-sense | 100218 | FDA UDI | Class II | Active |
| Coag-sense | 100221 | FDA UDI | Class II | Active |
| Coag-sense | 03F73-03 | FDA UDI | Class II | Active |
| Coag-Sense | 100107 | FDA UDI | Class II | Active |
| Coag-sense | 100222 | FDA UDI | Class II | Active |
| Coag-Sense Control Test Strip Kit - 10 Count | 03P69-10 | EUDAMEDFDA UDI | IVD General | Active |
| Coagusense Self-Test Prothrombin Time/Inr Monitoring System | K093243 | FDA 510(k) | Class II | Active |
| Coag-Sense Prothrombin Time (PT) /INR Monitoring System | 03P70-02 | EUDAMEDFDA UDI | IVD General | Active |
| Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit | 03P57-50 | EUDAMED | IVD General | Active |
| Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit | 03P56-50 | EUDAMEDFDA UDI | IVD General | Active |
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