Data / Medical devices / United Kingdom / Nissha Medical Technologies Limited
Nissha Medical Technologies Limited: FDA-registered device maker in Paignton Devon, United Kingdom, 1 510(k) clearance
Nissha Medical Technologies Limited is registered with the FDA (registration 3008933393) in Paignton Devon, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 23, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008933393
- Address
- Torbay Business Park Woodview Road, Paignton Devon, United Kingdom, TQ4 7HP
- Owner or operator
- Nissha Medical Technologies (9106359)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 7, 2012
- Registered through
- 2026
- Brand names listed
- BluFlex, ClearScan, EMS Electrodes, Guardian, Lead-Lok, Nissha Medical Technologies Neutral Electrodes - Boston Scientific, Nissha Medical Technologies Neutral Electrodes - Stryker, Nissha Medical Technologies Neutral Electrodes - Swaroplate and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 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 |
|---|---|---|---|---|---|---|
| February 23, 2021 | K203494 | Nissha Medical Technologies Neutral Electrodes | GEI | Substantially Equivalent | Nissha Medical Technologies, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Electrocardiograph
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated February 23, 2021. 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.