Shanguai Intco Import & Export Co. Ltd. · 89-08 · CHINA
For Shanguai Intco Import & Export 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 Face Mask; product code is 80 F - - XX Mask, Surgical; date published is 03/10/2017; address is 3rd Fl Building 9, No 188 Newjunhuan Rd. , Shanghai, CHINA, verified against its source on 2026-09-30.
- Firm
- Shanguai Intco Import & Export 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
- 3rd Fl Building 9, No 188 Newjunhuan Rd. , Shanghai, CHINA verified
- Date published
- 03/10/2017 verified
- Product code
- 80 F - - XX Mask, Surgical verified
- Product
- Face Mask verified
- FDA notes
- Device Classification is unknown verified
What the source says
Shanguai Intco Import & Export Co. Ltd. Date Published : 03/10/2017 3rd Fl Building 9, No 188 Newjunhuan Rd. , Shanghai, 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 - - XX Mask, Surgical Date Published: 11/08/2018 Desc: Face Mask Notes: Device Classification is unknown
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.