ZENUM SARL · 89-08 · SWITZERLAND

For ZENUM SARL, import alert is 89-08; country is SWITZERLAND; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test | SARS-CoV-2 IgG/IgM Rapid Test | ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - LW COVID-19 test home collection kit devices; date published is 03/02/2021; address is Route De La Corniche 3 , Epalinges, Vaud SWITZERLAND, verified against its source on 2026-09-30.

What the source says

ZENUM SARL Date Published : 03/02/2021 Route De La Corniche 3 , Epalinges, Vaud SWITZERLAND

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.