Shenzhen Beierkang Technology Co. Ltd. · 89-08 · CHINA
For Shenzhen Beierkang 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 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 2026-09-30.
- Firm
- Shenzhen Beierkang Technology Co. Ltd. verified
- 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
- Address
- 322 Jingkaidasha Qinghuyuan Longhua Area , Shenzhen, Guangdong CHINA verified
- Date published
- 04/20/2016 verified
- Product code
- 80 F - - LL Thermometer, Electronic, Clinical verified
- Product
- Multifunction Infrared Thermometer verified
- 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
What the source says
Shenzhen Beierkang Technology Co. Ltd. Date Published : 04/20/2016 322 Jingkaidasha Qinghuyuan Longhua Area , 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.
Product code, Product and FDA notes
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.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html