# Sorribes Online · 89-08 · DENMARK — FDA import alert red lists: firms subject to detention without physical examination

For Sorribes Online · 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 Jyllingehoj 2 , Jyllinge, DENMARK, verified against its source on 2026-09-16.

- **Firm:** Sorribes Online _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Jyllingehoj 2 , Jyllinge, DENMARK _(verified: appears in the quote below)_
- **Date published:** 03/28/2012 _(verified: appears in the quote below)_
- **Product code:** 79 F - - ZD Prosthesis, Ear, Internal | 79 H - - XD Clamp _(verified: each item appears in the quote below)_
- **Product:** Auri Kit; clamp ear pinning kit | Auri Kit; clamp ear pinning kit _(verified: each item appears in the quote below)_
- **FDA notes:** class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Sorribes Online Date Published : 03/28/2012 Jyllingehoj 2 , Jyllinge, 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).