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Sign in to claim this brandAgamatrix, Inc.
United States·US-MF-000039145
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 34, Route 111, Derry, United States
- Website
- agamatrix.com
- —
- —
- [email protected]
- Phone
- 1-866-906-4197
- PRRC Contact
- Dave Valcourt
- EUDAMED SRN
- US-MF-000039145
- FDA FEI Number
- 3004637226
- DUNS Number
- 156756129
Catalogue (44)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Agamatrix Wavesense Jazz Wireless meter | 8000-10409 | EUDAMED | IVD Annex II List B | Active |
| Agamatrix Control Solution Normal | 80003550 | EUDAMED | IVD Annex II List B | Active |
| Agamatrix Jazz Test Strips | 800003712 | EUDAMED | IVD Annex II List B | Active |
| AgaMatrix | 8000-01335 | FDA UDI | Class I | Active |
| AgaMatrix | 8000-03390 | FDA UDI | Class II | Active |
| CareSens S Fit | 8000-10972 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-04034 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-04025 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-10471 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-01971 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-01833 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-03764 | FDA UDI | Class I | Active |
| AgaMatrix | 8000-03334 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-10520 | FDA UDI | Class I | Active |
| AgaMatrix | 8000-10473 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-02661 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-10474 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-10472 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-04063 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-02013 | FDA UDI | Class I | Active |
| AgaMatrix | 8000-04940 | FDA UDI | Class II | Active |
| AgaMatrix Lancing Device | 8300-01325 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-04094 | FDA UDI | Class II | Active |
| CareSens S | 8000-10975 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-10519 | FDA UDI | Class I | Active |
| AgaMatrix | 8000-03909 | FDA UDI | Class II | Active |
| CareSens S | 8000-10974 | FDA UDI | Class II | Active |
| AgaMatrix Lancing Device | 8300-10622 | EUDAMEDFDA UDI | Class II | Active |
| AgaMatrix | 8000-02649 | FDA UDI | Class II | Active |
| AgaMatrix | 8000-04088 | FDA UDI | Class II | Active |
| Liberty Blood Glucose Monitoring System, Model 8000-0067 | K052762 | FDA 510(k) | Class II | Active |
| Jazz Wireless Blood Glucose Monitoring System, Model 8000-03381 | K083265 | FDA 510(k) | Class II | Active |
| Agamatrix Health Manager | K132821 | FDA 510(k) | Class II | Active |
| Zero-Click Data Management System, Model 8000-01528 | K062434 | FDA 510(k) | Class II | Active |
| WaveSense Jazz Blood Glucose Monitoring System | K241304 | FDA 510(k) | Class II | Active |
| AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System | K152365 | FDA 510(k) | Class II | Active |
| Liberty Blood Glucose Monitoring System, Model 8000-0067 | K063409 | FDA 510(k) | Class II | Active |
| Wavesense Diabetes Manager Model Version 1.3.4 | K101597 | FDA 510(k) | Class II | Active |
| Wavesense Keynote Codeless Blood Glucose Monitoring System | K073573 | FDA 510(k) | Class II | Active |
| Jazz Blood Glucose Monitoring System | K071393 | FDA 510(k) | Class II | Active |
| Modification To: Jazz Blood Glucose Monitoring System | K072413 | FDA 510(k) | Class II | Active |
| One Drop Blood Glucose Monitoring System | K161834 | FDA 510(k) | Class II | Active |
| Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D | K103544 | FDA 510(k) | Class II | Active |
| Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application | K130535 | FDA 510(k) | Class II | Active |
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