Data / Medical devices / Israel / Heramed Ltd.
Heramed Ltd.: FDA-registered device maker in Netanya Central, Israel, 1 510(k) clearance
Heramed Ltd. is registered with the FDA (registration 3017140411) in Netanya Central, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 14, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017140411
- Address
- 4 Hazoran St. POB 8576, Netanya Central, Israel, 4250604
- Owner or operator
- HeraMED Ltd. (10075667)
- Roles
- Manufacturer
- First device listed
- June 23, 2020
- Registered through
- 2026
- Brand names listed
- HeraBEAT US
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Ultrasonic, Fetal | KNG | 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 |
|---|---|---|---|---|---|---|
| November 14, 2019 | K191110 | HeraBEAT US | KNG | Substantially Equivalent | Heramed, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 14, 2019. 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.