# Jiangyin Binjiang Medical Equipment Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Jiangyin Binjiang Medical Equipment 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 Portable Electric Steam Sterilizer (Model SYL-280B); product code is 80 F - - LE Sterilizer, Steam; date published is 09/19/2011; address is Eastern Area of Chengjiang Town , Industrial Park , Jiangyin City, CHINA, verified against its source on 2026-09-16.

- **Firm:** Jiangyin Binjiang Medical Equipment 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:** Eastern Area of Chengjiang Town , Industrial Park , Jiangyin City, CHINA _(verified: appears in the quote below)_
- **Date published:** 09/19/2011 _(verified: appears in the quote below)_
- **Product code:** 80 F - - LE Sterilizer, Steam _(verified: appears in the quote below)_
- **Product:** Portable Electric Steam Sterilizer (Model SYL-280B) _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Jiangyin Binjiang Medical Equipment Co., Ltd. Date Published : 09/19/2011 Eastern Area of Chengjiang Town , Industrial Park , Jiangyin City, CHINA 80 F - - LE Sterilizer, Steam Date Published: 09/19/2011 Desc: Portable Electric Steam Sterilizer (Model SYL-280B) Notes: Class II

## 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/).