Suzhou Kangjie Medical Inc. · 89-08 · CHINA
For Suzhou Kangjie Medical Inc., 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 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 2026-09-30.
- Firm
- Suzhou Kangjie Medical Inc. 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
- Bldg 15, No 2, Shuangma St , Weiting Town , Suzhou, Jiangsu CHINA verified
- Date published
- 12/18/2020 verified
- Product code
- 86 H - - KX Tonometer, Ac-Powered verified
- Product
- Rebound Tonometer verified
What the source says
Suzhou Kangjie Medical Inc. Date Published : 12/18/2020 Bldg 15, No 2, Shuangma St , Weiting Town , Suzhou, Jiangsu 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 and Product
86 H - - KX Tonometer, Ac-Powered Date Published: 12/18/2020 Desc: Rebound Tonometer
— 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.