Reference Source

SHANGHAI TOP VIEW INDUSTRIAL CO Ltd · 89-08 · CHINA

For SHANGHAI TOP VIEW INDUSTRIAL 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 3388 Gonghexin Rd, Jingan , Shanghai, CHINA, verified against its source on 2026-09-16.

Firm
SHANGHAI TOP VIEW INDUSTRIAL 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
3388 Gonghexin Rd, Jingan , 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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

SHANGHAI TOP VIEW INDUSTRIAL CO Ltd Date Published : 09/02/2020 3388 Gonghexin Rd, Jingan , 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

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