Reference Source

Shanghai INTCO Medical Supply Co., Ltd. · 89-08 · CHINA

For Shanghai INTCO Medical Supply 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 1358 Hubin Lu , Fengxian , Shanghai, Shanghai CHINA, verified against its source on 2026-09-30.

Firm
Shanghai INTCO Medical Supply 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
1358 Hubin Lu , Fengxian , Shanghai, 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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Shanghai INTCO Medical Supply Co., Ltd. Date Published : 03/10/2017 1358 Hubin Lu , Fengxian , Shanghai, 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

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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