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

For Danamedic 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 code is 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical; date published is 09/16/2009; address is Maglebjergvej 1a , 4, Bostamose O Strade , Kgs. Lyngby, Hovedstaden DENMARK, verified against its source on 2026-09-16.

- **Firm:** Danamedic 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 1a , 4, Bostamose O Strade , Kgs. Lyngby, Hovedstaden DENMARK _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical _(verified: each item appears in the quote below)_
- **FDA notes:** Jes-Extender (penis extending device)12/18/2006 | Jes-Extender (penis Extending Device 12/18/2006 _(verified: each item appears in the quote below)_

## What the source says

> Danamedic Aps Date Published : 09/16/2009 Maglebjergvej 1a , 4, Bostamose O Strade , Kgs. Lyngby, Hovedstaden DENMARK 78 L - - KY Device, External Penile Rigidity Date Published: 09/16/2009 Notes: Jes-Extender (penis extending device)12/18/2006 78 N - - HU Extender, Penile, Mechanical Date Published: 09/16/2009 Notes: Jes-Extender (penis Extending Device 12/18/2006

## 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/).