BEDAL INTERNATIONAL
BE-MF-000001242 · Belgium · DIEPENBEEK
BEDAL INTERNATIONAL is registered in the European database on medical devices as a manufacturer, with 58 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 58 |
|---|
Most frequent device types declared: FlexGRIP.
Among these devices, 37 are declared sterile.
Devices declared under this manufacturer
- Bedal Flex S
- FlexGRIP Alpha CVC/Arterial NON STERILE
- FlexGRIP Alpha PICC/Midline
- FlexGRIP CVC 4,5-9 Fr
- FlexGRIP CVC 4.5-9 Fr
- FlexGRIP Jr. CVC 3 -6 Fr without Horseshoe, NON STERILE
- FlexGRIP Jr. Universal 5-11 Fr
- FlexGRIP Neo. A
- FlexGRIP Neo. PICC V
- FlexGRIP Neo. PIVC FS
- FlexGRIP Universal 11-18 Fr
- FlexGRIP Universal 18-25 Fr
Showing 12 of 58 declared devices.
Catalogue references include 1PICCNEO, ALPHA00, CVC45900, FLEXL-10; FLEXL-50, FLEXS-10; FLEXS-50, PICCNEOV.
European nomenclature codes declared: V9099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BEDAL International NV (BE) · FDA 3013415761 |
| Devices in EUDAMED | 58 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 58 |
|---|---|
| Found in the U.S. device database | 35 |
| Share | 60.3 % |
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. BEDAL INTERNATIONAL is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
BE24/00000301 | issued | 2029-11-27 |