MeMed BV
MeMed Diagnostics, Ltd.
MeMed Diagnostics Ltd
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011096386 | 3011096386 | MeMed Diagnostics Ltd | 1 | N | 2026-01-01 | 7 Nahum Het Street Tirat Carmel Haifa IL 3508506 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 296420 | 1116735716 | K230944 | MeMed BV | QPS | 2023-06-30 |
| 296420 | 1951205704 | K210254 | MeMed BV | QPS | 2021-09-01 |
| 296420 | 1603615913 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QPS | 2 | 2023-06-30 |
PMN#
GUDID#
MeMed BV® Calibrator - FG31001
2023-07-17
Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP - The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare professionals as a reference material to verify the analytical performance (precision, accuracy, and reportable range) of tests based on quantification of TRAIL/ IP-10/ CRP protein concentrations via the MeMed Key® analyzer platform. The performance verification kit is intended for in vitro diagnostic use only.
2022-09-22
MeMed BV® - FG10001
2021-12-06
MeMed Key® - FG130001
2021-10-26
MeMed BV® Calibrator - FG11001
2021-10-26
MeMed BV® External Control - FG12001
2021-10-26