Danamedic Aps · 89-08 · DENMARK
For Danamedic Aps, import alert is 89-08; country is DENMARK; 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 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 2026-09-30.
- 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
— 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 and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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