W&H Sterilization S.R.L.
ItalyFDA 510(k) applicant, unverified FDA FEI 3003947740
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What W&H Sterilization S.R.L. makes
W&H Sterilization S.R.L. manufactures dental sterilization devices, including the Lexa PLUS (RIS-311) and Lexa MINI models (RIS-303, RIS-305). These products are designed for sterilizing dental instruments and accessories using heat-based methods, ensuring compliance with infection control standards in dental practices.
The company’s portfolio consists of Class II medical devices, authorised through the FDA’s 510(k) clearance process. These devices are listed under the US regulatory framework and are intended for use in dental sterilisation procedures.
Catalogue
Lexa PLUS RIS-311 Ref K213758
510(k) 510(k)Lexa MINI (RIS-303, RIS-305) Ref K233504
510(k) 510(k)Lexa MINI (RIS-303, RIS-305) Ref K223858
CE MDR 510(k) 510(k)
Company details
- FDA FEI number
- 3003947740
- Address
- VIA BOLGARA, 2, BRUSAPORTO Bergamo
Frequently asked questions
How many devices does W&H Sterilization S.R.L. have in the registry?
The registry currently lists 3 devices for W&H Sterilization S.R.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list W&H Sterilization S.R.L.'s devices?
Among its 3 most recently registered devices, W&H Sterilization S.R.L. has devices listed in FDA 510(k) (3 devices).
What risk classes do W&H Sterilization S.R.L.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for W&H Sterilization S.R.L.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from W&H Sterilization S.R.L. in the registry?
The most recently registered devices listed for W&H Sterilization S.R.L. include Lexa PLUS RIS-311 and Lexa MINI (RIS-303, RIS-305).