Data / Medical devices / Israel / 3NT Medical Ltd.
3NT Medical Ltd.: FDA-registered device maker in Rosh Haayin Central, Israel, 2 510(k) clearances
3NT Medical Ltd. is registered with the FDA (registration 3016592765) in Rosh Haayin Central, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016592765
- Address
- 22 Hamelacha st. Building 3, Entrance B, POB 11384, Rosh Haayin Central, Israel, 4809169
- Owner or operator
- 3NT Medical LTD. (10062510)
- Roles
- Complaint file establishment
- First device listed
- March 8, 2020
- Registered through
- 2026
- Brand names listed
- 3NT Video Console, Colibri micro-ENT scope, Peregrine drivable ENT scope
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| July 23, 2021 | K202727 | Peregrine Endoscopy System | EOB | Substantially Equivalent | 3nt Medical , Ltd. | accessdata.fda.gov |
| February 27, 2020 | K192305 | Colibri Endoscopy System | EOB | Substantially Equivalent | 3nt Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 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.