4dimens Aps · 89-08 · DENMARK
For 4dimens 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 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 2026-09-30.
- 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
— 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, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html