Data / Medical devices / United Kingdom / Keypar Limited
Keypar Limited: FDA-registered device maker in Watford Hertfordshire, United Kingdom, 1 510(k) clearance
Keypar Limited is registered with the FDA (registration 3025915415) in Watford Hertfordshire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 11, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025915415
- Address
- 1 Cheshire Drive, Watford Hertfordshire, United Kingdom, WD25 7GP
- Owner or operator
- Keypar Limited (10093116)
- Roles
- Exporter to the US
- First device listed
- April 1, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Test, Time, Prothrombin | GJS | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| August 11, 2006 | K060978 | COAGUCHEK XS SYSTEM | GJS | Substantially Equivalent | Roche Diagnostics | accessdata.fda.gov |
Compare with other makers
Updated August 11, 2006. 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.