Data / Medical devices / Ireland / Enterasense Limited
Enterasense Limited: FDA-registered device maker in Galway Galway(County), Ireland, 1 510(k) clearance
Enterasense Limited is registered with the FDA (registration 3027502350) in Galway Galway(County), Ireland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 24, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027502350
- Address
- Block 4 Ballybrit Business Park, Galway Galway(County), Ireland, H91 A4XW
- Owner or operator
- EnteraSense Limited (10088270)
- Roles
- Manufacturer
- First device listed
- June 22, 2023
- Registered through
- 2026
- Brand names listed
- PillSense Capsule, PillSense Receiver
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Detection Capsule | QUD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2023 | DEN220065 | Pill Sense System | QUD | Unknown | Enterasense , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.