Shanguai Intco Import & Export Co. Ltd. · 89-08 · CHINA
For Shanguai Intco Import & Export 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 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 2026-09-16.
- 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 80 F - - XX Mask, Surgical Date Published: 11/08/2018 Desc: Face Mask Notes: Device Classification is unknown
— 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.