Danalife ApS · 89-08 · DENMARK
For Danalife 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 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 2026-09-30.
- Firm
- Danalife 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 4 , Lyngby, DENMARK verified
- Date published
- 05/30/2023 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity verified
- Product
- Penile Extender verified
What the source says
Danalife ApS Date Published : 05/30/2023 Maglebjergvej 4 , Lyngby, 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 Product
78 L - - KY Device, External Penile Rigidity Date Published: 05/30/2023 Desc: Penile Extender
— all from 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.