Rayonex Biomedical Gmbh · 89-08 · GERMANY

For Rayonex Biomedical Gmbh, import alert is 89-08; country is GERMANY; 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 RAYOCOMP PS 10 | RAYOCOMP PS 10 | Fabric Detector; 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 2026-09-30.

What the source says

Rayonex Biomedical Gmbh Date Published : 07/13/2016 Sauerland-Pyramiden 1 , Lennestadt, North Rhine-Westphalia GERMANY

— accessdata.fda.gov, retrieved 2026-09-22

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.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

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

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.