Ontex BV
BE-MF-000003544 · Belgium · Aalst
Ontex BV is registered in the European database on medical devices as a manufacturer, with 1 075 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 075 |
|---|
Most frequent device types declared: Heavy Inco, Light Inco, Underpads.
Devices declared under this manufacturer
- ASDA Protective Pads Extra 10pcs
- Continente discreet perdas de urina SUPER
- HEXA MEN Level 3 10pcs
- ID EXPERT SLIP M EXTRA PLUS -PE
- Inteno Safety Plus XL
- Secretisima Protege slip + compresa 2 en 1 x28
- Sensilind Complete Care Slip super small 1
- Sensilind Complete Care From maxi 8
- alvita PANTS FREE SAMPLE SUPER M
- iD Belt Maxi Extra Large
- iD Comfy Junior Pants 4-7 years
- iD Essential Pants Super M
Showing 12 of 1 075 declared devices.
Catalogue references include 10322061928, 14910101928, 15571441915, 5160040280, 5600270300CEE-01, 5700480140.
European nomenclature codes declared: T04010103, T04010199, T04010102, T04010201, T04010104, T04010101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Ontex BV (BE) · FDA 3010692191 |
| Devices in EUDAMED | 1 075 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 1 074 |
|---|---|
| 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: United States only. Ontex BV is registered in the United States but was not found in the Canadian register.