Shenzhen Cas-Envision Medical Technology Co., Ltd. · 89-08 · CHINA

For Shenzhen Cas-Envision Medical Technology Co., Ltd., import alert is 89-08; country is CHINA; 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 SARS-CoV-2 Antigen Rapid Detection Kit | SARS-CoV-2 Antigen Rapid Detection Kit; product code is 83 Q - - KP Coronavirus antigen detection test system. | 88 P - - PM General purpose reagent; date published is 04/05/2022; address is Bldg# F/4 , 4 Qidixiexin Science Park, No.333 Longfei Ave, Longcheng St; Longgang District , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.

What the source says

Shenzhen Cas-Envision Medical Technology Co., Ltd. Date Published : 04/05/2022 Bldg# F/4 , 4 Qidixiexin Science Park, No.333 Longfei Ave, Longcheng St; Longgang District , Shenzhen, Guangdong CHINA

— accessdata.fda.gov, retrieved 2026-09-15

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 2026-09-15

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.