Data / Medical devices / Ireland / Rockfield Medical Devices Ltd.
Rockfield Medical Devices Ltd.: FDA-registered device maker in Galway Galway(County), Ireland, 2 510(k) clearances
Rockfield Medical Devices Ltd. is registered with the FDA (registration 3017607339) in Galway Galway(County), Ireland. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 12, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017607339
- Address
- ATU iHub Galway Old Dublin Road, Galway Galway(County), Ireland, H91 DCH9
- Owner or operator
- Rockfield Medical Devices Ltd (10087042)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- January 5, 2023
- Registered through
- 2026
- Brand names listed
- Mobility+ Bag, Mobility+ Enteral Feeding System, Mobility+ Enteral Feeding System OTC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Garment, Storage, Peritoneal Dialysis Catheter | OAG | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 12, 2024 | K233034 | Mobility+ Enteral Feeding System OTC | PIF | Substantially Equivalent | Rockfield Medical | accessdata.fda.gov |
| October 27, 2022 | K222678 | Mobility+ Enteral Feeding System | PIF | Substantially Equivalent | Rockfield Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
- All makers of Garment, Storage, Peritoneal Dialysis Catheter
Updated April 12, 2024. 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.