4dimens Aps · 89-08 · DENMARK
For 4dimens 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 Auri Kit; Clamp ear pinning kit | Auri Kit; Clamp ear pinning kit; product code is 79 F - - ZD Prosthesis, Ear, Internal | 79 H - - XD Clamp; date published is 03/28/2012; address is Jyllingehoej 2 , Jyllingejyllinge, DENMARK, verified against its source on 2026-09-16.
- Firm
- 4dimens 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
- Jyllingehoej 2 , Jyllingejyllinge, DENMARK verified
- Date published
- 03/28/2012 verified
- Product code
- 79 F - - ZD Prosthesis, Ear, Internal | 79 H - - XD Clamp each item verified
- Product
- Auri Kit; Clamp ear pinning kit | Auri Kit; Clamp ear pinning kit each item verified
- FDA notes
- class II | Class II each item verified
What the source says
4dimens Aps Date Published : 03/28/2012 Jyllingehoej 2 , Jyllingejyllinge, DENMARK 79 F - - ZD Prosthesis, Ear, Internal Date Published: 03/28/2012 Desc: Auri Kit; Clamp ear pinning kit Notes: class II 79 H - - XD Clamp Date Published: 03/28/2012 Desc: Auri Kit; Clamp ear pinning kit Notes: Class II
— 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.