Data / Medical devices / Israel / MeMed Diagnostics Ltd
MeMed Diagnostics Ltd: FDA-registered device maker in Tirat Carmel Haifa, Israel, 2 510(k) clearances
MeMed Diagnostics Ltd is registered with the FDA (registration 3011096386) in Tirat Carmel Haifa, Israel. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011096386
- Address
- 7 Nahum Het Street, Tirat Carmel Haifa, Israel, 3508506
- Owner or operator
- Qsite (10082733)
- Roles
- Manufacturer
- First device listed
- September 25, 2021
- Registered through
- 2026
- Brand names listed
- MeMed BV, Memed BV, Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Immunoassay For Host Biomarkers Of Infection | QPS | 2 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | 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 |
|---|---|---|---|---|---|---|
| June 30, 2023 | K230944 | MeMed BV | QPS | Substantially Equivalent | MeMed Diagnostics, Ltd. | accessdata.fda.gov |
| September 1, 2021 | K210254 | MeMed BV | QPS | Substantially Equivalent | MeMed Diagnostics, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Immunoassay For Host Biomarkers Of Infection
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
Updated June 30, 2023. 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.