Data / Medical devices / United Kingdom / Optimum Medical
Optimum Medical: FDA-registered device maker in West Yorkshire Leeds, United Kingdom, 1 510(k) clearance
Optimum Medical is registered with the FDA (registration 3009086335) in West Yorkshire Leeds, United Kingdom. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 10, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009086335
- Address
- Tennant Hall Bleinheim Grove, West Yorkshire Leeds, United Kingdom, LS2 9ET
- Owner or operator
- Optimum Medical (10041088)
- Roles
- Exporter to the US, Foreign private label distributor, Specification developer
- First device listed
- June 19, 2012
- Registered through
- 2026
- Brand names listed
- Multi Fix Gentle, Nexus, OptiLube, OptiPure, Ovio Cup, Sheath (Male External Catheters), Ugo 2L Drainage Bags, Ugo 4 Weeks and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Foreign private label distributor | accessdata.fda.gov |
| Cup, Menstrual | HHE | 2 | Foreign private label distributor | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Exporter to the US | accessdata.fda.gov |
| Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile | NNY | 1 | Foreign private label distributor | accessdata.fda.gov |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | NNZ | 1 | Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | 1 | Specification developer | accessdata.fda.gov |
| Urinary Drainage Collection Kit | PPG | 2 | Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | 2 | Exporter to the US, Foreign private label distributor, 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 |
|---|---|---|---|---|---|---|
| April 10, 2012 | K112110 | STERILE LUBRICATING JELLY | KMJ | Substantially Equivalent | Jianerkang Medical Dressing Company | accessdata.fda.gov |
Compare with other makers
- All makers of Cup, Menstrual
- All makers of Catheter, Retention Type, Balloon
- All makers of Urinary Drainage Collection Kit, For Indwelling Catheter
- All makers of Urinary Drainage Collection Kit
- All makers of Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
- All makers of System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
Updated April 10, 2012. 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.