IT CONCEPTS GMBH

FDA Device Registration & Listing · Lahnau Hesse, DE · Registration 3009118476

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009118476
FEI Number
3009118476
Entity Name
IT CONCEPTS GMBH
City/State/Country
Lahnau Hesse, DE
Establishment Address
Gewerbestrasse 17, IT Concepts GmbH, Lahnau Hesse 35633, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
IT Concepts GmbH (Owner Number: 10058477)
Owner / Operator Contact Address
Gewerbestrasse 17, IT Concepts GmbH, Lahnau, DE-HE 35633, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

VIOT Otoscope OX2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2018-10-04

Official Correspondent

No official correspondent registered.

US Agent Details

Alla Balashov Business: Balashov Email: alla@itconceptsworld.com Phone: (925) 4010010

Related Public Records

Same Entity

IT Concepts 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
K932506 Rudolf Riester GmbH & Co. KG RI-SCOPE (S) 1993-10-08

Similar Registrations

Registration Number Establishment Name Location
3016854720 REMMIE INC Seattle, WA, US
3010181894 UNITED SCIENCES Atlanta, GA, US
3030410270 Deebo Warehouse Raleigh, NC, US
3030089857 Nordes Sp. z o.o. Wroclaw Dolnoslaskie, PL
9614434 STORZ ENDOSKOP PRODUKTIONS GMBH SCHAFFHAUSEN, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009118476. Last updated year: 2026. Please use registration number 3009118476 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.