# Damiva Inc · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For Damiva Inc · 89-08 · CANADA, 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 CANADA; product is Mae Vaginal Suppository | Mae Vaginal Suppository; product code is 62 M - - 99 Anti-Pruritic N.E.C. | 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible; date published is 12/13/2017; address is 639 Dupont St Unit 228 , Toronto, Ontario CANADA, verified against its source on 2026-09-16.

- **Firm:** Damiva Inc _(verified: appears in the quote below)_
- **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:** CANADA _(verified: appears in the quote below)_
- **Address:** 639 Dupont St Unit 228 , Toronto, Ontario CANADA _(verified: appears in the quote below)_
- **Date published:** 12/13/2017 _(verified: appears in the quote below)_
- **Product code:** 62 M - - 99 Anti-Pruritic N.E.C. | 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible _(verified: each item appears in the quote below)_
- **Product:** Mae Vaginal Suppository | Mae Vaginal Suppository _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device without a valid 510K | Class II device without a valid 510K _(verified: each item appears in the quote below)_

## What the source says

> Damiva Inc Date Published : 12/13/2017 639 Dupont St Unit 228 , Toronto, Ontario CANADA 62 M - - 99 Anti-Pruritic N.E.C. Date Published: 12/13/2017 Desc: Mae Vaginal Suppository Notes: Class II device without a valid 510K 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible Date Published: 12/13/2017 Desc: Mae Vaginal Suppository Notes: Class II device without a valid 510K

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).