Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616031

FEI Number

3000231474

Entity Name

GETINGE DISINFECTION AB

City/State/Country

VAXJO Kronoberg, SE

Establishment Address

LJUNGADALSGATAN 11, VAXJO Kronoberg 352 46, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Getinge (Owner Number: 9057664)

Owner / Operator Contact Address

Ljungadalsgatan 11, VAXJO, SE-G 352 46, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Model 1150 - Lumen tray only Ultrasonic Cleaning System - Triton 36 Triton series - Lumen tray only Model 1101 RACS tray with S and SI adapters Model 1101 - Lumen Tray only Ultrasonic Cleaning System - Model 1522 Triton series - Lumen tray with an accessory kit SP Tray with adapters - Model 1101 Triton RACS tray S and Si with adapters Triton RACS Tray X and Xi with adapters Ultrasonic Cleaning System - Model 1100 Triton RACS Xi Tray - Tray only Ultrasonic Cleaning System - Model 1150 Ultrasonic Cleaning System - Model 1101 Model 1150 - Lumen tray with Accessory kit Triton RACS tray Xi with SP Adapters Xi RACS tray with adapters for Model 1101 Hospital wire mesh tray Getinge Aquadis PCU Model 1100 - Lumen tray only Model 1101 - Lumen Tray with Accessory kit Model 1100 - Lumen Tray with Accessory Kit Ultrasonic Cleaning System -Triton 72 Models 8666, 8668, S-8668T Model CM320 Models 46-4, 46-5 Models 9120E, 9122E, 9125E, 9127E, 9128E, 9128EW Aquadis 56 washer disinfector Models 9120, 9122, 9125 and 9128 Getinge Aquadis Index

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	1992-12-15
MEC	Disinfector, Medical Devices	General Hospital	Class 2	880.6992	1993-11-10

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Valerio Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

Getinge

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012092534	Getinge Group Logistics America, LLC	E Windsor, NJ, US
3012068831	Getinge IC Production Poland sp. z o.o.	Plewiska Wielkopolskie, PL
2028456	STERITEC PRODUCTS MFG. CO., INC.	Englewood, CO, US

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.
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616031. Last updated year: 2026. Please use registration number 9616031 when referencing this establishment in official correspondence.