Data / Medical devices / Israel / Medcu Technologies Ltd.
Medcu Technologies Ltd.: FDA-registered device maker in Herzliya Central, Israel, 1 510(k) clearance
Medcu Technologies Ltd. is registered with the FDA (registration 3015374187) in Herzliya Central, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 23, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015374187
- Address
- 11 Galgalei Haplada, Herzliya Central, Israel, 4672200
- Owner or operator
- MedCu Technologies Ltd. (10080458)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 3, 2021
- Registered through
- 2026
- Brand names listed
- Antibacterial wound dressings with copper
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| November 23, 2018 | K180643 | MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) | FRO | Substantially Equivalent | Medcu Technologies , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 23, 2018. 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.