Data / Medical devices / United Kingdom / MD Diagnostics Ltd
MD Diagnostics Ltd: FDA-registered device maker in Chatham Kent, United Kingdom, 2 510(k) clearances
MD Diagnostics Ltd is registered with the FDA (registration 3009896423) in Chatham Kent, United Kingdom. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 25, 2019. 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
- 3009896423
- Address
- Slip 7 Annexe The Historic Dockyard, Chatham Kent, United Kingdom, ME4 4TZ
- Owner or operator
- MD Diagnostics Ltd (10045293)
- Roles
- Manufacturer
- First device listed
- November 4, 2013
- Registered through
- 2026
- Brand names listed
- CARBON MONOXIDE MONITOR, H2 Check, SafeBreath Filter Mouthpiece
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | CCJ | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer | accessdata.fda.gov |
| Gas Chromatograph, Carbon-Monoxide | JKT | 1 | Manufacturer | accessdata.fda.gov |
| System, Breath Measurement | NRH | 1 | 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 |
|---|---|---|---|---|---|---|
| September 25, 2019 | K190022 | SafeBreath Filter Mouthpiece | CAH | Substantially Equivalent | MD Diagnostics Limited | accessdata.fda.gov |
| March 2, 2018 | K171129 | CO Check Pro, CO Screen | CCJ | Substantially Equivalent | MD Diagnostics Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Gas Chromatograph, Carbon-Monoxide
- All makers of Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- All makers of System, Breath Measurement
- All makers of Filter, Bacterial, Breathing-Circuit
Updated September 25, 2019. 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.