BETATEX SPA
IT-MF-000009955 · Italy · ASSISI
BETATEX SPA is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 3 |
|---|---|
| Class IIa | 7 |
| Class IIb | 3 |
Most frequent device types declared: KIT SPECIALISTICI E SET SALA OPERATORIA, Lacci vascolari - Vascular loops, MTK1058/ISK-19, MTK1076/FCR1, SB0039SE.
Among these devices, 13 are declared sterile.
Devices declared under this manufacturer
- CUSTOM PACK CATARATTA
- KIT PER CATETERISMO VESCICALE
- LACCI VASCOLARI
- M-connect - CONNECTING TUBE MLL 3WAYS STOPCOCK/FUNNEL 15CM
- MTT1010/BX-15_AV2 A SET PROCEDURALE CHIR
- PICC LINE DRESSING KIT
- PICC Line Dressing Kit
- SET BY PASS AORTOCORONARICO
- SET NEURORADIOLOGIA
- SIRINGA GEL LUBRIFICANTE
- TECNODRAPE
- TELO 75X120 CM IN SUPER ASSORBENTE
Showing 12 of 13 declared devices.
Catalogue references include MTK1076/FCR1, MTT04560-I, MTT0590-I, PICC Line Dressing Kit, SB0039SE, SE0164SEA.
European nomenclature codes declared: T0202, T02010102, T0203, T0299, V9099, V901699.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 13 |
| 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 | 7 |
|---|---|
| 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. BETATEX SPA was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CVD001823 | issued | 2027-10-23 |
CVD001723 | issued | 2027-10-23 |