Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027434168

FEI Number

3027434168

Entity Name

Tuttnauer Kft.

City/State/Country

Dunakeszi Pest, HU

Establishment Address

43 Pallag Utca, Dunakeszi Pest 2120, HU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TUTTNAUER LTD. (Owner Number: 8030087)

Owner / Operator Contact Address

HAR-TUV B INDUSTRIAL ZONE, BEIT SHEMESH, IL-JM 9910101, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090783

PMA Number

N/A

All Registered Proprietary Names

Tuttnauer Horizontal models 4472, 5596, 6690, 66120, 69120, 69180 EZ9, EZ11, EZ15 - PLUS 1730, 2340, 2540, 3870 E/EK/EP, EZ9, EZ10, 3870 E/M, 2340, 2540, 3870 EA/EKA Tuttnauer Steam Sterilizer 3870HSG and 3870HSG-WS 4472, 5596 Tuttnaier Table Top Autoclave Tuttnauer Steam Sterilizer ELARA11 T-Edge10 T-Edge 11 T-Top 10, T-Top 11 1730, 2340, 2540, 3870 - E 6690, 66120, 69150, 6990, 69120, 69180 6690, 66120, 69150, 6990, 69120, 69180 ELARAII Elara 11 T-Edge10

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2019-10-22
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2011-12-14
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2010-12-23
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2010-12-23
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2022-12-19
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2010-12-23
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2019-10-22
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2015-02-10
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-03-12
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2019-10-22
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2007-12-07
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2007-12-07
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2010-12-23

Official Correspondent

Keren Ziv

US Agent Details

Guy Lerner Business: Tuttnauer USA Email: glerner@tuttnauerusa.com Phone: (516) 3146011

Related Public Records

Same Entity

TUTTNAUER LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8030087	TUTTNAUER LTD.	BEIT SHEMESH Jerusalem, IL

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

Similar Registrations

Registration Number	Establishment Name	Location
1219189	CONSOLIDATED MACHINE CORP.	Billerica, MA, US
3005899764	STERIS MEXICO, S. de R.L. de C.V.	GUADALUPE Nuevo Leon, MX
8030087	TUTTNAUER LTD.	BEIT SHEMESH Jerusalem, IL
3022516928	DENT4YOU AG	Heerbrugg Sankt Gallen, CH
3012068831	Getinge IC Production Poland sp. z o.o.	Plewiska Wielkopolskie, PL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027434168. Last updated year: 2026. Please use registration number 3027434168 when referencing this establishment in official correspondence.