# Suzhou Kangjie Medical Inc. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Suzhou Kangjie Medical Inc. · 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 Rebound Tonometer; product code is 86 H - - KX Tonometer, Ac-Powered; date published is 12/18/2020; address is Bldg 15, No 2, Shuangma St , Weiting Town , Suzhou, Jiangsu CHINA, verified against its source on 2026-09-16.

- **Firm:** Suzhou Kangjie Medical Inc. _(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:** Bldg 15, No 2, Shuangma St , Weiting Town , Suzhou, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 12/18/2020 _(verified: appears in the quote below)_
- **Product code:** 86 H - - KX Tonometer, Ac-Powered _(verified: appears in the quote below)_
- **Product:** Rebound Tonometer _(verified: appears in the quote below)_

## What the source says

> Suzhou Kangjie Medical Inc. Date Published : 12/18/2020 Bldg 15, No 2, Shuangma St , Weiting Town , Suzhou, Jiangsu CHINA 86 H - - KX Tonometer, Ac-Powered Date Published: 12/18/2020 Desc: Rebound Tonometer

## 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/).