Data / Medical devices / United Kingdom / MEDOVATE Ltd
MEDOVATE Ltd: FDA-registered device maker in Mildenhall Suffolk, United Kingdom, 1 510(k) clearance
MEDOVATE Ltd is registered with the FDA (registration 3017907746) in Mildenhall Suffolk, United Kingdom. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 31, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017907746
- Address
- 96 Hampstead Avenue, Mildenhall Suffolk, United Kingdom, IP28 7AS
- Owner or operator
- Medovate Ltd (10079605)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 16, 2022
- Registered through
- 2026
- Brand names listed
- Cipher OpClear, SAFIRA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Irrigation/Suction System | OCX | 2 | Contract manufacturer | accessdata.fda.gov |
| Pump, Air, Non-Manual, For Endoscope | FEQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Pump, Infusion | FRN | 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 |
|---|---|---|---|---|---|---|
| October 31, 2023 | K230083 | SAFIRA | FRN | Substantially Equivalent | Medovate Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Air, Non-Manual, For Endoscope
- All makers of Endoscopic Irrigation/Suction System
- All makers of Pump, Infusion
Updated October 31, 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.