Data / Medical devices / United Kingdom / Quanta Dialysis Technologies Ltd
Quanta Dialysis Technologies Ltd: FDA-registered device maker in Warwick Warwickshire, United Kingdom, 1 510(k) clearance
Quanta Dialysis Technologies Ltd is registered with the FDA (registration 3013536188) in Warwick Warwickshire, United Kingdom. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 10, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013536188
- Address
- The Woods Haywood Road, Warwick Warwickshire, United Kingdom, CV34 5AH
- Owner or operator
- Quanta Dialysis Technologies Ltd (10080477)
- Roles
- Specification developer
- First device listed
- May 20, 2021
- Registered through
- 2026
- Brand names listed
- Bicarbonate Spare Connectors Set, Blood Tube Set, Clinic Water Cart, Dialysate Cartridge, Home Water Cart, Quanta Dialysis System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Specification developer | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | Specification developer | accessdata.fda.gov |
| System, Hemodialysis, Remote Accessories | MON | 1 | 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 |
|---|---|---|---|---|---|---|
| November 10, 2022 | K222067 | SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set | KDI | Substantially Equivalent | Quanta Dialysis Technologies, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- All makers of System, Hemodialysis, Remote Accessories
Updated November 10, 2022. 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.