TePe Munhygienprodukter AB
SE-MF-000015961 · Sweden · Malmö
TePe Munhygienprodukter AB is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 9 |
|---|
Most frequent device types declared: Orthodontic kit, TePe Mouth Prop, TePe Oral Swab.
Devices declared under this manufacturer
- Orthodontic wax
- TePe Mouth Prop Large
- TePe Mouth Prop Small
- TePe Oral Swab Large
- TePe Oral Swab Large Single Pack
- TePe Oral Swab Lubricating
- TePe Oral Swab Saliva Stimulating
- TePe Oral Swab Small
- TePe Oral Swab Small Single Pack
Catalogue references include 842409, 871515, 871615, 871715, 871716, 871717.
European nomenclature codes declared: Q010499.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TEPE MUNHYGIENPRODUKTER AB (SE) · FDA 3003761382 |
| Devices in EUDAMED | 9 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| 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. TePe Munhygienprodukter AB is registered in the United States but was not found in the Canadian register.