Gaodin Medical Shanghai Co Ltd · 89-08 · CHINA
For Gaodin Medical Shanghai 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 Rebound Tonometer; product code is 86 H - - KX Tonometer, Ac-Powered; date published is 12/18/2020; address is # 1004 Rong Xin Buidling No.1851north , Shanghai, Shanghai CHINA, verified against its source on 2026-09-16.
- Firm
- Gaodin Medical Shanghai 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
- # 1004 Rong Xin Buidling No.1851north , Shanghai, Shanghai 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
Gaodin Medical Shanghai Co Ltd Date Published : 12/18/2020 # 1004 Rong Xin Buidling No.1851north , Shanghai, Shanghai CHINA 86 H - - KX Tonometer, Ac-Powered Date Published: 12/18/2020 Desc: Rebound Tonometer
— 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.