# Shenzhen Imdk Medical Technology Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shenzhen Imdk Medical Technology 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 Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1 | Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 | Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 | Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1; 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 2026-09-16.

- **Firm:** Shenzhen Imdk Medical Technology 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:** 904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street, , Guangming District , Shenzhen, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 06/08/2022 _(verified: appears in the quote below)_
- **Product code:** 73 D - - QA Oximeter | 73 D - - QA Oximeter | 74 O - - CH Oximeter, infrared, sporting, aviation | 74 O - - CH Oximeter, infrared, sporting, aviation _(verified: each item appears in the quote below)_
- **Product:** Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1 | Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 | Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 | Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1 _(verified: each item appears in the quote below)_

## 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 73 D - - QA Oximeter Date Published: 06/08/2022 Desc: Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1 73 D - - QA Oximeter Date Published: 06/08/2022 Desc: Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 74 O - - CH Oximeter, infrared, sporting, aviation Date Published: 06/08/2022 Desc: Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 74 O - - CH Oximeter, infrared, sporting, aviation Date Published: 06/08/2022 Desc: Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1

## 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/).