Data / Medical devices / United Kingdom / Mediplus Ltd.
Mediplus Ltd.: FDA-registered device maker in HIGH WYCOMBE, BUCKS Buckinghamshire, United Kingdom, 2 510(k) clearances
Mediplus Ltd. is registered with the FDA (registration 9617192) in HIGH WYCOMBE, BUCKS Buckinghamshire, United Kingdom. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 17, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9617192
- FEI number
- 3011308139
- Address
- Unit 7 The Gateway Centre Coronation RD Cressex Bus. PK., HIGH WYCOMBE, BUCKS Buckinghamshire, United Kingdom, HP12 3SU
- Owner or operator
- MEDIPLUS LTD. (9041147)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- April 24, 2000
- Registered through
- 2027
- Brand names listed
- Capnomask, Catheter Accessories, MEDIPLUS URODYNAMICS STERILE, NON-STERILE CATHETERS, S-Cath
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Catheter, Suprapubic (And Accessories) | KOB | 2 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Device, Cystometric, Hydraulic | FEN | 2 | Complaint file establishment, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| January 17, 2014 | K132890 | SUPRAPUBIC CATHETER AND INTRODUCER SET | KOB | Substantially Equivalent | Mediplus , Ltd. | accessdata.fda.gov |
| November 25, 2013 | K131339 | CAPNOMASK | CCK | Substantially Equivalent | Mediplus , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Cystometric, Hydraulic
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Accessories, Catheter
- All makers of Catheter, Suprapubic (And Accessories)
Updated January 17, 2014. 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.