Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2435367

FEI Number

2435367

Entity Name

TUTTNAUER USA CO. LTD.

City/State/Country

HAUPPAUGE, NY, US

Establishment Address

345 Oser Avenue, --, HAUPPAUGE, NY 11788, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TUTTNAUER USA CO. LTD. (Owner Number: 1450514)

Owner / Operator Contact Address

345 Oser Avenue, --, Hauppauge, NY 11788, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143311

PMA Number

N/A

All Registered Proprietary Names

EZ9 plus, EZ11 Plus T-Edge 11 120V T-Edge 11 230V T-Edge 10 230V T-Edge 10 120V 3870 HSG WS 3870 HSG 6690, 66120, 69150, 6990, 69120, 69180 2340M 2540M Valueklave 1730MK T-Top 11 230V T-Top 10 120V T-Top 10 230V T-Top 11 120V 2540EEKEAEKA 3870EA, 3870EAP 2340EKA EZ9 EZ10, EZ10P Elara II, 5075 HSG MD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-12-19
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-11-26
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-11-26
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2007-12-12
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2007-12-12
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-11-26
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2007-12-12
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-12-19

Official Correspondent

Keren Ziv

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TUTTNAUER USA CO. LTD.

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
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 2435367. Last updated year: 2026. Please use registration number 2435367 when referencing this establishment in official correspondence.