Reference Source

Incosmo S.R.L · 89-08 · ITALY

For Incosmo S.R.L, import alert is 89-08; country is ITALY; 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 Long-Lasting Personal Lubricant | Long-Lasting Personal Lubricant | Long-Lasting Personal Lubricant; product code is 80 K - - MJ Lubricant, Patient | 80 M - - MS Lubricant, Vaginal, Patient | 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible; date published is 03/20/2018; address is Via I Maggio 7 , Biassono, Monza E della Brianza ITALY, verified against its source on 2026-09-30.

Firm
Incosmo S.R.L 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
ITALY verified
Address
Via I Maggio 7 , Biassono, Monza E della Brianza ITALY verified
Date published
03/20/2018 verified
Product code
80 K - - MJ Lubricant, Patient | 80 M - - MS Lubricant, Vaginal, Patient | 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible each item verified
Product
Long-Lasting Personal Lubricant | Long-Lasting Personal Lubricant | Long-Lasting Personal Lubricant 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

Incosmo S.R.L Date Published : 03/20/2018 Via I Maggio 7 , Biassono, Monza E della Brianza ITALY

— 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

80 K - - MJ Lubricant, Patient Date Published: 03/20/2018 Desc: Long-Lasting Personal Lubricant 80 M - - MS Lubricant, Vaginal, Patient Date Published: 03/20/2018 Desc: Long-Lasting Personal Lubricant 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible Date Published: 03/20/2018 Desc: Long-Lasting Personal Lubricant

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

Source

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

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