# Danalife ApS · 89-08 · DENMARK — FDA import alert red lists: firms subject to detention without physical examination

For Danalife ApS · 89-08 · DENMARK, 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 DENMARK; product is Penile Extender; product code is 78 L - - KY Device, External Penile Rigidity; date published is 05/30/2023; address is Maglebjergvej 4 , Lyngby, DENMARK, verified against its source on 2026-09-16.

- **Firm:** Danalife ApS _(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:** DENMARK _(verified: appears in the quote below)_
- **Address:** Maglebjergvej 4 , Lyngby, DENMARK _(verified: appears in the quote below)_
- **Date published:** 05/30/2023 _(verified: appears in the quote below)_
- **Product code:** 78 L - - KY Device, External Penile Rigidity _(verified: appears in the quote below)_
- **Product:** Penile Extender _(verified: appears in the quote below)_

## What the source says

> Danalife ApS Date Published : 05/30/2023 Maglebjergvej 4 , Lyngby, DENMARK 78 L - - KY Device, External Penile Rigidity Date Published: 05/30/2023 Desc: Penile Extender

## 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/).