Danalife ApS · 89-08 · DENMARK
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
- 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 78 L - - KY Device, External Penile Rigidity Date Published: 05/30/2023 Desc: Penile Extender
— 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.