TITAMED
BE-MF-000000110 · Belgium · Kontich
TITAMED is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 18 |
|---|---|
| Class IIb | 6 |
Most frequent device types declared: Benders, Cutters, Distractor Keys, Distractors, Forceps.
Among these devices, 6 are declared implantable.
Devices declared under this manufacturer
- Bending pliers simple
- Handle medium
- Key for Smile EXTRA
- Plate bending handles G15-G20
- Plate bending handles G20-G25
- Plate bending pliers
- Plate cutting plier
- Plate cutting plier strong
- Plate holding forceps, angled
- UNI-Smile Distractor, 14mm
- UNI-Smile Distractor, 16mm
- UNI-Smile Distractor, 18mm
Showing 12 of 24 declared devices.
Catalogue references include DSA014, DSA016, DSA022, DSA024, IT01-155, IT02-200.
European nomenclature codes declared: Z12139099, P09120403, L098002, S010401.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TITAMED (ZA) · FDA 3008754074 |
| Devices in EUDAMED | 24 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 24 |
|---|---|
| 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. TITAMED is registered in the United States but was not found in the Canadian register.