Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015276821

FEI Number

3015276821

Entity Name

Ushio Poland SP. z o.o

City/State/Country

Blonie Mazowieckie, PL

Establishment Address

Pass,UI, Stefana Batarego 17, Blonie Mazowieckie 05-870, PL

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	2020-02-27
LEJ	Booth, Sun Tan	General, Plastic Surgery	Class 2	878.4635	2020-02-26

Official Correspondent

Heinz-Juergen Wesseling

US Agent Details

Michelle Robertson Email: MRobertson@ushio.com Phone: (714) 2293175

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
8010905	USHIO GERMANY GmbH	Steinhoering Bavaria, DE

Related 510(k) Records

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

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3003994709	NARVA Lichtquellen GmbH + Co. KG	Brand-Erbisdorf Saxony, DE
8022254	TANSES TECHNOLOGIES, INC.	FABREVILLE Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015276821. Last updated year: 2026. Please use registration number 3015276821 when referencing this establishment in official correspondence.