Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030087

FEI Number

3005343391

Entity Name

TUTTNAUER LTD.

City/State/Country

BEIT SHEMESH Jerusalem, IL

Establishment Address

HAR-TUV INDUSTRIAL ZONE, BOX 170, BEIT SHEMESH Jerusalem 9910101, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

N/A

PMA Number

N/A

All Registered Proprietary Names

EZ9, EZ11, EZ15 - PLUS Tuttnauer Steam Sterilizer T-EDGE 10 & T-EDGE 11 Tuttnauer Steam Sterilizer Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye T-Top 10, T-Top 11 ELARAII Elara 11 T-Edge10 Tuttnaier Table Top Autoclave 6690, 66120, 69150, 6990, 69120, 69180 1730, 2340, 2540, 3870 E/EK/EP, EZ9, EZ10, 3870 E/M, 2340, 2540, 3870 EA/EKA Terragene Chemdye Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222- 6690, 66120, 69150, 6990, 69120, 69180 1730, 2340, 2540, 3870 - E Tuttnauer Steam Sterilizer Tuttnauer Horizontal models 4472, 5596, 6690, 66120, 69120, 69180 4472, 5596 TIVA 2 &, TIVA 8 TIVA 2 &, TIVA 8, TIVA 10

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2011-12-14
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2022-01-05
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2024-07-23
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2024-07-23
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-03-12
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	2007-12-07
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2010-12-23
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2024-07-23
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2024-07-23
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2007-12-07
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2019-10-22
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	2010-12-23
LDS	Device, Pasteurization, Hot Water	General Hospital	Class 2	880.6991	2022-01-19

Official Correspondent

No official correspondent registered.

US Agent Details

Guy Lerner Business: Tuttnauer USA Co. Ltd. Email: glerner@tuttnauerusa.com Phone: (800) 6245836

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
3027434168	Tuttnauer Kft.	Dunakeszi Pest, HU

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
K151482	Bcr Diagnostics, Inc.	BCR-30-min BI and RBIP-ST30 Readout Accessory	2016-02-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0036-2011	Cenorin	2	HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 520*FOR SALES.SERVICE.SUPPLIES CALLCenorin Kent, WA 98032P:800.426.1042F: 253.395.2650*www.cenorin.com". Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended to use at healthcare provide clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean and high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.
Z-0037-2011	Cenorin	2	HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). This device does not have the external heater unit known as High Throughput Heater. Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 540*FOR SALES.SERVICE.SUPPLIES CALLCenorin Kent, WA 98032P:800.426.1042F: 253.395.2650*www.cenorin.com". Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended for use at healthcare provided clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.
Z-0038-2011	Cenorin	2	The HLD SYSTEM 540HT is a Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). The Model 540HT has an external heater (aka High Throughput Heater). This external heater is connected through hoses to the device and may be secured to a wall. This external heater reduces the pasteurization cycle time by heating the water to higher temperatures. Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 540HT*FOR SALES.SERVICE.SUPPLIES CALLCenorin Kent, WA 98032P:800.426.1042F: 253.395.2650*www.cenorin.com". Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended for use at healthcare provided clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.
Z-0039-2011	Cenorin	2	The Routine Service Kit #082395-00 or Part #030500-00 for HLD SYSTEM and it is labeled in part: "HLD SYSTEMS *FOR SALES.SERVICE.SUPPLIES CALLCenorin Kent, WA 98032P:800.426.1042F: 253.395.2650*www.cenorin.com". Service Kit P/N: 082395-00 Series 500 Water Level Switch Upgrade Kit: The purpose of this service kit was to provide replacement parts for customers who had HLD Systems that were manufactured prior to 3/22/07.These systems were manufactured with old, old switches that have been obsolete and discontinued. Part P/N: 030500-00 Switch, Liquid Level: This part was sold by itself to a foreign consignee in Japan for inventory purposes only for regularly scheduled maintenance of a device or replacement of parts at the end of their normal life expectancy.

Similar Registrations

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3005899764	STERIS MEXICO, S. de R.L. de C.V.	GUADALUPE Nuevo Leon, MX
3022516928	DENT4YOU AG	Heerbrugg Sankt Gallen, CH
3012068831	Getinge IC Production Poland sp. z o.o.	Plewiska Wielkopolskie, PL
3027434168	Tuttnauer Kft.	Dunakeszi Pest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030087. Last updated year: 2026. Please use registration number 8030087 when referencing this establishment in official correspondence.