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

For Shenzhen Imdk 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 Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1 | Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 | Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1 | Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2; product code is 73 D - - QA Oximeter | 73 D - - QA Oximeter | 74 O - - CH Oximeter, infrared, sporting, aviation | 74 O - - CH Oximeter, infrared, sporting, aviation; date published is 06/08/2022; address is 904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street, , Guangming District , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.

What the source says

Shenzhen Imdk Medical Technology Co., Ltd. Date Published : 06/08/2022 904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street, , Guangming District , Shenzhen, Guangdong CHINA

— 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.