EU → North America Device Access

W&H Sterilization Srl

IT-MF-000008237 · Italy · Brusaporto (BG)

W&H Sterilization Srl is registered in the European database on medical devices as a manufacturer, with 204 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIb191
Class IIa13

Most frequent device types declared: 13730, 13735, 35362, 36749, 38671.

Among these devices, 183 are declared active.

Devices declared under this manufacturer

Showing 12 of 204 declared devices.

Catalogue references include 19932189, 19943101, 19943410, 19945101, 19951154, 19952232.

European nomenclature codes declared: Z12011305, Z1103030102, Z12011301, S01020101, Z1103040102, S9099.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryW&H STERILIZATION S.R.L. (IT) · FDA 3003947740
Devices in EUDAMED204
Country of registrationItaly

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN7
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryW&H STERILIZATION S.R.L.

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record5
Currently active0
Class 2 devices5
First licensed2004-04-30

Licence types: Device Family (3), Single Device (2).

Licensed under: LISA MB-22, LISA MB-17, MN-111, LEXA PLUS RIS-311, LEXA MINI.

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