Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003947740

FEI Number

3003947740

Entity Name

W&H STERILIZATION S.R.L.

City/State/Country

BRUSAPORTO Bergamo, IT

Establishment Address

VIA BOLGARA, 2, BRUSAPORTO Bergamo 24060, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

W&H STERILIZATION S.R.L. (Owner Number: 9056923)

Owner / Operator Contact Address

Via Bolgara, 2, Brusaporto, IT-BG I-24060, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233504

PMA Number

N/A

All Registered Proprietary Names

Lexa PLUS RIS-311 MN-111 Talos+ (RIW-100UC, RIW-100TT) Lexa MINI (RIS-303, RIS-305)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2022-09-01
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2018-07-02
LDS	Device, Pasteurization, Hot Water	General Hospital	Class 2	880.6991	2025-12-18
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-02-15

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

W&H STERILIZATION S.R.L.

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003947740. Last updated year: 2026. Please use registration number 3003947740 when referencing this establishment in official correspondence.