Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011255064

FEI Number

3011255064

Entity Name

RAYONEX BIOMEDICAL GMBH

City/State/Country

Lennestadt North Rhine-Westphalia, DE

Establishment Address

Sauerland-Pyramiden 1, Lennestadt North Rhine-Westphalia 57368, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Rayonex Biomedical GmbH (Owner Number: 10060235)

Owner / Operator Contact Address

Sauerland-Pyramiden 1, Lennestadt, DE-NW 57368, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rayocomp PS 10

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2019-05-17

Official Correspondent

Cara-Jo Heimes

US Agent Details

Gregory Orr Business: Sustainable Health Solutions Email: shsmail@icloud.com Phone: (740) 8173319

Related Public Records

Same Entity

Rayonex Biomedical GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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3004642067	NEUROCONN GMBH	Ilmenau Thuringia, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011255064. Last updated year: 2026. Please use registration number 3011255064 when referencing this establishment in official correspondence.