# ZENUM SARL · 89-08 · SWITZERLAND — FDA import alert red lists: firms subject to detention without physical examination

For ZENUM SARL · 89-08 · SWITZERLAND, import alert is 89-08; 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)"; country is SWITZERLAND; product is SARS-CoV-2 IgG/IgM Rapid Test | ZEKCOV19 3 ZEKMED COVID19 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 2026-09-16.

- **Firm:** ZENUM SARL _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** SWITZERLAND _(verified: appears in the quote below)_
- **Address:** Route De La Corniche 3 , Epalinges, Vaud SWITZERLAND _(verified: appears in the quote below)_
- **Date published:** 03/02/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - LW COVID-19 test home collection kit devices _(verified: each item appears in the quote below)_
- **Product:** SARS-CoV-2 IgG/IgM Rapid Test | ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test | ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test _(verified: each item appears in the quote below)_

## What the source says

> ZENUM SARL Date Published : 03/02/2021 Route De La Corniche 3 , Epalinges, Vaud SWITZERLAND 83 Q - - KO Reagent, coronavirus serological Date Published: 08/25/2021 Desc: SARS-CoV-2 IgG/IgM Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 03/02/2021 Desc: ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test 83 Q - - LW COVID-19 test home collection kit devices Date Published: 03/02/2021 Desc: ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).