Reference Source

Megasol Cosmetic GmbH · 89-08 · GERMANY

For Megasol Cosmetic GmbH, import alert is 89-08; country is GERMANY; 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 EROS Brand Cosmetic Gels personal lubricants; product code is 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible; date published is 01/08/2013; address is Jean-Monnet-Str. 6 , Fohren, Rhineland-Palatinate GERMANY, verified against its source on 2026-09-30.

Firm
Megasol Cosmetic GmbH 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
GERMANY verified
Address
Jean-Monnet-Str. 6 , Fohren, Rhineland-Palatinate GERMANY verified
Date published
01/08/2013 verified
Product code
85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible verified
Product
EROS Brand Cosmetic Gels personal lubricants verified
FDA notes
Class II verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Megasol Cosmetic GmbH Date Published : 01/08/2013 Jean-Monnet-Str. 6 , Fohren, Rhineland-Palatinate GERMANY

— 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, Product and FDA notes

85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible Date Published: 01/08/2013 Desc: EROS Brand Cosmetic Gels personal lubricants Notes: Class II

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

Source

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