# FUAN (SHANGHAI) ENTERPRISE DEVELOPMENT CO., LTD. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For FUAN (SHANGHAI) ENTERPRISE DEVELOPMENT 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 | Rebound Tonometer | Rebound Tonometer | Rebound Tonometer; product code is 86 H - - KX Tonometer, Ac-Powered | 86 H - - KY Tonometer, Manual | 86 H - - KZ Sterilizer, Tonometer | 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear); date published is 09/02/2020; address is 6th Floor , 2049 38 Lane , Shanghai, Shanghai CHINA, verified against its source on 2026-09-16.

- **Firm:** FUAN (SHANGHAI) ENTERPRISE DEVELOPMENT 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:** 6th Floor , 2049 38 Lane , Shanghai, Shanghai CHINA _(verified: appears in the quote below)_
- **Date published:** 09/02/2020 _(verified: appears in the quote below)_
- **Product code:** 86 H - - KX Tonometer, Ac-Powered | 86 H - - KY Tonometer, Manual | 86 H - - KZ Sterilizer, Tonometer | 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) _(verified: each item appears in the quote below)_
- **Product:** Rebound Tonometer | Rebound Tonometer | Rebound Tonometer | Rebound Tonometer _(verified: each item appears in the quote below)_

## What the source says

> FUAN (SHANGHAI) ENTERPRISE DEVELOPMENT CO., LTD. Date Published : 09/02/2020 6th Floor , 2049 38 Lane , Shanghai, Shanghai CHINA 86 H - - KX Tonometer, Ac-Powered Date Published: 09/02/2020 Desc: Rebound Tonometer 86 H - - KY Tonometer, Manual Date Published: 09/02/2020 Desc: Rebound Tonometer 86 H - - KZ Sterilizer, Tonometer Date Published: 09/02/2020 Desc: Rebound Tonometer 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) Date Published: 09/02/2020 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/).