Reference Source

Shanghai Realov Electronic Technology Co Ltd · 89-08 · CHINA

For Shanghai Realov Electronic Technology 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 Renegade Bolero Pump | Renegade Bolero Pump; product code is 78 L - - KY Device, External Penile Rigidity | 85 K - - XQ Vibrator For Therapeutic Use, Genital; date published is 09/28/2017; address is Floor 3 , 799/26 Middle Jia Song Road , Shanghai, Shanghai CHINA, verified against its source on 2026-09-16.

Firm
Shanghai Realov Electronic Technology 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
Floor 3 , 799/26 Middle Jia Song Road , Shanghai, Shanghai CHINA verified
Date published
09/28/2017 verified
Product code
78 L - - KY Device, External Penile Rigidity | 85 K - - XQ Vibrator For Therapeutic Use, Genital each item verified
Product
Renegade Bolero Pump | Renegade Bolero Pump 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 Realov Electronic Technology Co Ltd Date Published : 09/28/2017 Floor 3 , 799/26 Middle Jia Song Road , Shanghai, Shanghai CHINA 78 L - - KY Device, External Penile Rigidity Date Published: 09/28/2017 Desc: Renegade Bolero Pump 85 K - - XQ Vibrator For Therapeutic Use, Genital Date Published: 09/28/2017 Desc: Renegade Bolero Pump

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

Source

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