Produits Dentaires SA
CH-MF-000023147 · Switzerland · Vevey
Produits Dentaires SA is registered in the European database on medical devices as a manufacturer, with 225 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 225 |
|---|
Among these devices, 9 are declared implantable, 25 reusable.
Authorised representative in the Union: PD DENTAL EU SAS.
Devices declared under this manufacturer
- 4mm Medium 1S Perforated Diamond finish with gap
- Articulating Papers Straight, blue/red, thick
- EDTA 17%
- Irriflex
- Matrix Bands Type 8 Thin N°10
- NiTi needle N°2
- ODUS - Pella Transparent Crown Forms - Assortment box of 18 pairs, R&L
- ODUS Universal Strips Straight, 6mm
- Pella Transparent Crown Forms - N°202 - Box of 6 pairs
- Plunger N°2
- Pro-Pul-Pan
- Tofflemire Matrix Bands Thin N°1
Showing 12 of 225 declared devices.
Catalogue references include 10260, 11569, 20212, 21401, 33761, 41514.
European nomenclature codes declared: Q01020502, Q010299, Q010199, Q01010403, Q019004, Q010599.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PRODUITS DENTAIRES SA (CH) · FDA 8010414 |
| Devices in EUDAMED | 225 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 205 |
|---|---|
| Found in the U.S. device database | 133 |
| Share | 64.9 % |
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. Produits Dentaires SA is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CH24/00000115 | issued | 2029-11-28 |
0425-MDR-030163-01 | issued | 2030-10-27 |