Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013394987

FEI Number

3013394987

Entity Name

LUXAMED GMBH & CO. KG

City/State/Country

Blaubeuren Baden-Wurttemberg, DE

Establishment Address

Daniel-Weil-Strasse 3, Blaubeuren Baden-Wurttemberg 89143, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LUXAMED GmbH & Co. KG (Owner Number: 10054010)

Owner / Operator Contact Address

Daniel-Weil-Strasse 3, Blaubeuren, DE-BW 89143, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LUXAMED LuxaScope Auris LED

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2023-05-02
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2017-02-21

Official Correspondent

Matthias Dubb

US Agent Details

David Kemp Business: Oaktree Products Email: DKemp@oaktreeproducts.com Phone: (636) 5301664

Related Public Records

Same Entity

LUXAMED GmbH & Co. KG

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
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13
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 3013394987. Last updated year: 2026. Please use registration number 3013394987 when referencing this establishment in official correspondence.