# Rayonex Biomedical Gmbh · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For Rayonex Biomedical Gmbh · 89-08 · GERMANY, 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 GERMANY; product is RAYOCOMP PS 10 | Fabric Detector | RAYOCOMP PS 10; product code is 68 Z - - 99 Animal Medical Devices, NEC | 84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief) | 84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief); date published is 07/13/2016; address is Sauerland-Pyramiden 1 , Lennestadt, North Rhine-Westphalia GERMANY, verified against its source on 2026-09-16.

- **Firm:** Rayonex Biomedical Gmbh _(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:** GERMANY _(verified: appears in the quote below)_
- **Address:** Sauerland-Pyramiden 1 , Lennestadt, North Rhine-Westphalia GERMANY _(verified: appears in the quote below)_
- **Date published:** 07/13/2016 _(verified: appears in the quote below)_
- **Product code:** 68 Z - - 99 Animal Medical Devices, NEC | 84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief) | 84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief) _(verified: each item appears in the quote below)_
- **Product:** RAYOCOMP PS 10 | Fabric Detector | RAYOCOMP PS 10 _(verified: each item appears in the quote below)_

## What the source says

> Rayonex Biomedical Gmbh Date Published : 07/13/2016 Sauerland-Pyramiden 1 , Lennestadt, North Rhine-Westphalia GERMANY 68 Z - - 99 Animal Medical Devices, NEC Date Published: 09/06/2024 Desc: RAYOCOMP PS 10 84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief) Date Published: 07/13/2016 Desc: Fabric Detector 84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief) Date Published: 07/13/2016 Desc: RAYOCOMP PS 10

## 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/).