Data / Medical devices / United Kingdom / KEYMED (Medical & Industrial Equipment) Ltd
KEYMED (Medical & Industrial Equipment) Ltd: FDA-registered device maker in SOUTHEND-ON-SEA Essex, United Kingdom, 4 510(k) clearances
KEYMED (Medical & Industrial Equipment) Ltd is registered with the FDA (registration 9611174) in SOUTHEND-ON-SEA Essex, United Kingdom. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 6, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9611174
- FEI number
- 1000162602
- Address
- KeyMed House Stock Road, SOUTHEND-ON-SEA Essex, United Kingdom, SS2 5QH
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 3, 2008
- Registered through
- 2027
- Brand names listed
- AD-CO2- OUS, ADA-CO2-OUS, BW-400B, BW-400L, BW-400V, BW-403B, BW-411B, BW-412T, MA-392 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Specification developer | accessdata.fda.gov |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Specification developer | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Specification developer | accessdata.fda.gov |
| Endoscopic Irrigation/Suction System | OCX | 2 | Specification developer | accessdata.fda.gov |
| Extractor, Vacuum, Fetal | HDB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pump, Air, Non-Manual, For Endoscope | FEQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | 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 |
|---|---|---|---|---|---|---|
| April 6, 2020 | K193250 | Irrigation Tubing with CO2 or Air | OCX | Substantially Equivalent | Keymed (Medical and Industrial Equipment) , Ltd. | accessdata.fda.gov |
| December 9, 2016 | K162205 | Arc EndoCuff and Arc EndoCuff Vision | FED | Substantially Equivalent | Boddingtons Plastics, Ltd. | accessdata.fda.gov |
| October 11, 2013 | K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | BTA | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| September 13, 2010 | K100899 | OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 | FEQ | Substantially Equivalent | Keymed (Medical & Industrial Equipment), Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Accessories, Photographic, For Endoscope (Exclude Light Sources)
- All makers of Extractor, Vacuum, Fetal
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of Endoscopic Bite Block
- All makers of Tubing/Tubing With Filter, Insufflation, Laparoscopic
Updated April 6, 2020. 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.