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Sign in to claim this brandMonarch Medical Technologies, LLC
US
Last updated May 30, 2026
Information
- Country
- US
- Address
- —
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
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- DUNS Number
- 078665793
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EndoTool IV | EndoTool IV 2.0 | FDA UDI | Class II | Active |
| EndoTool SubQ | SubQ 2.0 | FDA UDI | Class II | Active |
| EndoTool IV | 3.1 | FDA UDI | Class II | Active |
| EndoTool | None | FDA UDI | Class II | Active |
| Endo Tool Glucose Management System (egms) | K132547 | FDA 510(k) | Class II | Active |
| EndoTool SubQ | K142918 | FDA 510(k) | Class II | Active |
| EndoTool IV 1.10 | K200443 | FDA 510(k) | Class II | Active |
| EndoTool SubQ 2.1 | K211160 | FDA 510(k) | Class II | Active |
| EndoTool IV System | K201619 | FDA 510(k) | Class II | Active |
| EndoTool IV (3.1) | K241088 | FDA 510(k) | Class II | Active |
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FDA Recalls (2)
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 |
|---|---|---|---|---|
| Oct 1, 2019 | Z-0354-2020 | — | terminated | Product was distributed prior to approval or clearance from FDA. |
| May 3, 2019 | Z-1786-2019 | — | open, classified | Insulin dosing calculations were erroneously high. |