Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008344687

FEI Number

3008344687

Entity Name

KEN Hygiene Systems A/S

City/State/Country

Broby Syddanmark, DK

Establishment Address

Boegebjergvej 60, Broby Syddanmark 5672, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KEN Hygiene Systems A/S (Owner Number: 10032167)

Owner / Operator Contact Address

Boegebjergvej 60, Broby, DK-83 5672, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Skytron Sterling P1500 Skytron Sterling P1000 Skytron Sterling C2000 Skytron Sterling P1800 Skytron Sterling M1000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEC	Disinfector, Medical Devices	General Hospital	Class 2	880.6992	2016-02-08

Official Correspondent

Ole Nielsen

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

KEN Hygiene Systems A/S

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2026	Getinge Disinfection Ab Ljungadalsgatan	2	Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Z-0018-2014	Getinge Disinfection Ljungadalsgatan	2	Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

Similar Registrations

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3005544459	STEELCO S.P.A.	Riese Pio X Treviso, IT
3018520804	ZHONGSHAN SUNCLEAN CO.,LTD	Zhongshan Guangdong, CN
8021896	ALBERT BROWNE LTD.	LEICESTER, GB
3017293064	XIAMEN FORSOUND HEARING TECHNOLOGY CO.,LTD.	Xiamen Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008344687. Last updated year: 2026. Please use registration number 3008344687 when referencing this establishment in official correspondence.