Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010905

FEI Number

3425

Entity Name

USHIO GERMANY GmbH

City/State/Country

Steinhoering Bavaria, DE

Establishment Address

Muenchener Strasse 10, Steinhoering Bavaria 85643, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

USHIO GERMANY GmbH (Owner Number: 10028997)

Owner / Operator Contact Address

Muenchener Strasse 10, Steinhoering, DE-BY 85643, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KBL smartSunlight HP700

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LEJ	Booth, Sun Tan	General, Plastic Surgery	Class 2	878.4635	2020-02-26
LEJ	Booth, Sun Tan	General, Plastic Surgery	Class 2	878.4635	2020-02-27

Official Correspondent

Heinz-Juergen Wesseling

US Agent Details

Michelle Robertson Business: Ushio America Inc. Email: mrobertson@ushio.com Phone: (714) 2293133

Related Public Records

Same Entity

USHIO GERMANY GmbH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015276821	Ushio Poland SP. z o.o	Blonie Mazowieckie, PL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K875190	Ultra Tan Intl. AB	ULTRA TAN PURPLE PRO	1988-01-14

Similar Registrations

Registration Number	Establishment Name	Location
3015276821	Ushio Poland SP. z o.o	Blonie Mazowieckie, PL
3007123863	UNILAM CO., LTD.	Ulju-Gun Ulsan, KR
3006116732	KBL GmbH	Dernbach Rhineland-Palatinate, DE
9680413	ULTRASUN	HENGELO Overijssel, NL
3003994709	NARVA Lichtquellen GmbH + Co. KG	Brand-Erbisdorf Saxony, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010905. Last updated year: 2026. Please use registration number 8010905 when referencing this establishment in official correspondence.