Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009010438

FEI Number

3009010438

Entity Name

ORLVISION GMBH

City/State/Country

Lahnau Hesse, DE

Establishment Address

Gewerbestrasse 17, Lahnau Hesse 35633, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Orlvision GmbH (Owner Number: 10061627)

Owner / Operator Contact Address

Gewerbestrasse 17, Lahnau, DE-HE 35633, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150248

PMA Number

N/A

All Registered Proprietary Names

Otoscope OX2 ORL Video Nasopharyngo-laryngoscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2020-03-07
EQN	Laryngoscope, Nasopharyngoscope	Ear, Nose, Throat	Class 2	874.4760	2019-11-05

Official Correspondent

Oliver Neumann

US Agent Details

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

Related Public Records

Same Entity

Orlvision 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009010438. Last updated year: 2026. Please use registration number 3009010438 when referencing this establishment in official correspondence.