Santex S.p.A.
IT-MF-000010188 · Italy · MILANO
Santex S.p.A. is registered in the European database on medical devices as a manufacturer, with 592 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 592 |
|---|
Most frequent device types declared: COMPRESSE PIEGATE STERILI, GARZE IN COTONE TAGLIATE SENZA FILO RX NON STERILI, GARZE PIEGATE STERILI, Pannoloni mutandina con fissaggio con cintura, Pannoloni mutandina X-Dry con fissaggio integrato tipo Pants.
Among these devices, 144 are declared sterile.
Devices declared under this manufacturer
- Absorbeo Pants Extra size Large
- BENDE IN GARZA IDROFILA NON STERILE
- Egosan Flex Maxi size Medium
- Egosan Flex Super size Large
- Egosan Pants Extra size Extra-Large
- Egosan Rectangular Pads with outer layer
- Egosan SLIP Pad holding mesh panties size L
- Egosan Underpads cm 40x60 Extra
- Egosan X-DRY Pants Iper size X-Large
- GARZE IN COTONE PIEGATE STERILI
- GARZE IN COTONE TAGLIATE SENZA FILO RX NON STERILI
- IPER Adult Pannoloni Rettangolari
Showing 12 of 592 declared devices.
Catalogue references include BI7D0505S, GN3A1010S, IED43D0709F05S, XPUX61B-2, XRE1B-30, ZSR30.
European nomenclature codes declared: T04010103, M0201020101,M0201020201, T04010102, M0201030101,M0201030201, M0201050101,M0201050201, M0201030102,M0201030202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 592 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 592 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Santex S.p.A. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 00155-A | issued | 2030-06-17 |