# SHENZHEN WATMIND MEDICAL CO LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For SHENZHEN WATMIND MEDICAL CO LTD · 89-08 · CHINA, 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 CHINA; product is SARS-CoV-2 IgG & IgM Ab Test Kit (Colloidal Gold); product code is 83 Q - - KO Reagent, coronavirus serological; date published is 04/20/2022; address is 8th Floor , Building A, No. 16-1, Jinhui Road, Jinsha Community, Kengzi Subdistrict; Pingshan District , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** SHENZHEN WATMIND MEDICAL CO LTD _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** 8th Floor , Building A, No. 16-1, Jinhui Road, Jinsha Community, Kengzi Subdistrict; Pingshan District , Shenzhen, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 04/20/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological _(verified: appears in the quote below)_
- **Product:** SARS-CoV-2 IgG & IgM Ab Test Kit (Colloidal Gold) _(verified: appears in the quote below)_

## What the source says

> SHENZHEN WATMIND MEDICAL CO LTD Date Published : 04/20/2022 8th Floor , Building A, No. 16-1, Jinhui Road, Jinsha Community, Kengzi Subdistrict; Pingshan District , Shenzhen, Guangdong CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 04/20/2022 Desc: SARS-CoV-2 IgG & IgM Ab Test Kit (Colloidal Gold)

## 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/).