Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680413

FEI Number

3004531930

Entity Name

ULTRASUN

City/State/Country

HENGELO Overijssel, NL

Establishment Address

GRANAATSTRAAT 6, HENGELO Overijssel 7554 TR, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ultrasun International B.V. (Owner Number: 9008844)

Owner / Operator Contact Address

Granaatstraat 6, Hengelo, NL-OV 7554 TR, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Q18 i8 E6 UltraSun I8 Q14 Q6-0 Q6-2 Q10 i9 Q22 SunFit Lamp DR MUELLER COLLASHOWER 48 WITH VIBRAPLATE UltraSun Air Filter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTC	Light, Ultraviolet, Dermatological	General, Plastic Surgery	Class 2	878.4630	2023-02-24
LEJ	Booth, Sun Tan	General, Plastic Surgery	Class 2	878.4635	2023-02-24
LEJ	Booth, Sun Tan	General, Plastic Surgery	Class 2	878.4635	2018-08-15
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2023-10-30
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2022-01-26

Official Correspondent

No official correspondent registered.

US Agent Details

Shepard Bentley Business: Bentley Biomedical Consulting, LLC Email: bob@fdalistingconsultants.com Phone: (949) 3749187

Related Public Records

Same Entity

Ultrasun International B.V.

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
K800950	Tanit, Inc.	TANIT HOME SUNTANNING UNIT	1980-06-04
K230382	Daavlin Distributing Co.	3 Series NeoLux	2023-03-24
K875190	Ultra Tan Intl. AB	ULTRA TAN PURPLE PRO	1988-01-14

Similar Registrations

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1526255	THE DAAVLIN DISTRIBUTING CO.	Bryan, OH, US
3004167969	ALMA LASERS LTD.	CAESAREA Northern, IL
3008872264	PSORIA-SHIELD INC	Utica, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680413. Last updated year: 2026. Please use registration number 9680413 when referencing this establishment in official correspondence.