FUAN (SHANGHAI) ENTERPRISE DEVELOPMENT CO., LTD. · 89-08 · CHINA
For FUAN (SHANGHAI) ENTERPRISE DEVELOPMENT CO., LTD., 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 | 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 2026-09-30.
- Firm
- FUAN (SHANGHAI) ENTERPRISE DEVELOPMENT 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
- 6th Floor , 2049 38 Lane , Shanghai, Shanghai CHINA verified
- Date published
- 09/02/2020 verified
- 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) each item verified
- Product
- Rebound Tonometer | Rebound Tonometer | Rebound Tonometer | Rebound Tonometer each item verified
What the source says
FUAN (SHANGHAI) ENTERPRISE DEVELOPMENT CO., LTD. Date Published : 09/02/2020 6th Floor , 2049 38 Lane , Shanghai, Shanghai 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: 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html