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Sign in to claim this brandLUCID DIAGNOSTICS, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 200 Foxborough Boulevard, Foxborough, MA, 02035
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3016490370
- DUNS Number
- —
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EsoCheck CCD Cell Collection Device | 260-03614 | FDA UDI | Class II | Active |
| EsoCheck CCD Cell Collection Device | 230-05203 | FDA UDI | Class II | Active |
| EsoCheck Cell Collection Device | K230339 | FDA 510(k) | Class II | Active |
| EsoCheck Cell Collection Device | K222366 | FDA 510(k) | Class II | Active |
| EsoCheck Cell Collection Device | K210137 | FDA 510(k) | Class II | Active |
| EsoCheck CCD Cell Collection Device | K183262 | FDA 510(k) | Class II | Active |
Related Companies
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Authorities
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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 |
|---|---|---|---|---|
| Apr 24, 2024 | Z-1899-2024 | — | open, classified | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal. |
| Apr 24, 2024 | Z-1900-2024 | — | open, classified | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal. |