Rayonex Biomedical Gmbh · 89-08 · GERMANY

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.

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

— accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.