Data / Medical devices / Israel / Sensomedical Labs Ltd
Sensomedical Labs Ltd: FDA-registered device maker in nazareth Northern, Israel, 1 510(k) clearance
Sensomedical Labs Ltd is registered with the FDA (registration 3019467229) in nazareth Northern, Israel. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 17, 2026. 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
- 3019467229
- Address
- Nazareth industrial parks building, mount precipice st 2015, nazareth Northern, Israel, 1612102
- Owner or operator
- sensomedical labs ltd (10096030)
- Roles
- Manufacturer
- First device listed
- June 10, 2026
- Registered through
- 2026
- Brand names listed
- C360 Clinical Electrode Cable, Wovyn Depth Electrode
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Depth | GZL | 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 |
|---|---|---|---|---|---|---|
| April 17, 2026 | K253970 | Wovyn Depth Electrode | GZL | Substantially Equivalent | Sensomedical Labs, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 17, 2026. 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.