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

For Shenzhen Beierkang 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 Multifunction Infrared Thermometer; product code is 80 F - - LL Thermometer, Electronic, Clinical; date published is 04/20/2016; address is 322 Jingkaidasha Qinghuyuan Longhua Area , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Shenzhen Beierkang 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:** 322 Jingkaidasha Qinghuyuan Longhua Area , Shenzhen, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 04/20/2016 _(verified: appears in the quote below)_
- **Product code:** 80 F - - LL Thermometer, Electronic, Clinical _(verified: appears in the quote below)_
- **Product:** Multifunction Infrared Thermometer _(verified: appears in the quote below)_
- **FDA notes:** Class II Device. The Agency is unable to determine if the product is a device subject to a previously cleared 510(K) due to the lack of information in the product materials. _(verified: appears in the quote below)_

## What the source says

> Shenzhen Beierkang Technology Co. Ltd. Date Published : 04/20/2016 322 Jingkaidasha Qinghuyuan Longhua Area , Shenzhen, Guangdong CHINA 80 F - - LL Thermometer, Electronic, Clinical Date Published: 04/20/2016 Desc: Multifunction Infrared Thermometer Notes: Class II Device. The Agency is unable to determine if the product is a device subject to a previously cleared 510(K) due to the lack of information in the product materials.

## 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/).