Orfit Industries
BE-MF-000007872 · Belgium · Wijnegem
Orfit Industries is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 31 |
|---|
Most frequent device types declared: 0028, 0030, Head Supports, Orfitrans, Patient Support Cushions.
Devices declared under this manufacturer
- Block Small
- Full Body Cushion for Cyberknife Couch Top
- Head Support Model 1 With Lateral Neck Flaps
- Head Support Model 2 WITHOUT LATERAL NECK FLAPS
- Head Support Model 5 With Lateral Neck Flaps
- Medium Block
- Set of 10 support cushions
- Set of 3 Head Supports with lateral neck flap
- Set of 6 Head Supports (all models)
- Short Truncal Cushion 50cm x 40cm x 2cm
- The AIO Solution
- The AIO Solution® (All-in-One Patient Positioning Solution)
Showing 12 of 31 declared devices.
Catalogue references include 32005/16-V2, 32005/4-V2, 32005/8-V2, 32118, 32470, 32476.
European nomenclature codes declared: Z11010980, Z11010480, Z11010180, T030401, Y061299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ORFIT INDUSTRIES NV (BE) · FDA 9613183 |
| Devices in EUDAMED | 31 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| Found in the U.S. device database | 20 |
| Share | 64.5 % |
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. Orfit Industries is registered in the United States but was not found in the Canadian register.