Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012068831

FEI Number

3012068831

Entity Name

Getinge IC Production Poland sp. z o.o.

City/State/Country

Plewiska Wielkopolskie, PL

Establishment Address

Szkolna 30, Plewiska Wielkopolskie 62-064, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

GSS610N21 Series Steam Sterilizer Model 733HC-E Getinge 400HC-E/500HC-E Series Steam Sterilizer GSS67N Steam Sterilizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-12-09
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2012-07-11
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2013-04-04
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2018-01-31

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
9616031	GETINGE DISINFECTION AB	VAXJO Kronoberg, SE
2028456	STERITEC PRODUCTS MFG. CO., INC.	Englewood, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012068831. Last updated year: 2026. Please use registration number 3012068831 when referencing this establishment in official correspondence.