Data / Medical devices / Italy / W&H Sterilization S.R.L.
W&H Sterilization S.R.L.: FDA-registered device maker in BRUSAPORTO Bergamo, Italy, 4 510(k) clearances
W&H Sterilization S.R.L. is registered with the FDA (registration 3003947740) in BRUSAPORTO Bergamo, Italy. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003947740
- Address
- Via Bolgara, 2, BRUSAPORTO Bergamo, Italy, 24060
- Owner or operator
- W&H STERILIZATION S.R.L. (9056923)
- Roles
- Manufacturer
- First device listed
- July 2, 2018
- Registered through
- 2026
- Brand names listed
- Lexa MINI (RIS-303, RIS-305), Lexa PLUS RIS-311, MN-111, Talos+ (RIW-100UC, RIW-100TT)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Pasteurization, Hot Water | LDS | 2 | Manufacturer | accessdata.fda.gov |
| Sterilizer, Steam | FLE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 8, 2024 | K233504 | Lexa MINI (RIS-303, RIS-305) | FLE | Substantially Equivalent | W&H Sterilization S.R.L. | accessdata.fda.gov |
| May 5, 2023 | K223858 | Lexa MINI (RIS-303, RIS-305) | FLE | Substantially Equivalent | W&H Sterilization S.R.L. | accessdata.fda.gov |
| August 19, 2022 | K213758 | Lexa PLUS RIS-311 | FLE | Substantially Equivalent | W&H Sterilization S.R.L. | accessdata.fda.gov |
| May 30, 2018 | K172825 | MN-111 | FLE | Substantially Equivalent | W&H Sterilization S.R.L. | accessdata.fda.gov |
Compare with other makers
Updated February 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.