FUAN (SHANGHAI) ENTERPRISE DEVELOPMENT CO., LTD. · 89-08 · CHINA

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.

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

— accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.