Danamedic Aps · 89-08 · DENMARK
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
- 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
- Address
- Maglebjergvej 1a , 4, Bostamose O Strade , Kgs. Lyngby, Hovedstaden DENMARK verified
- Date published
- 09/16/2009 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical each item verified
- FDA notes
- Jes-Extender (penis extending device)12/18/2006 | Jes-Extender (penis Extending Device 12/18/2006 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.