edelweiss dentistry products gmbh
AT-MF-000005413 · Austria · Wolfurt
edelweiss dentistry products gmbh is registered in the European database on medical devices as a manufacturer, with 413 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 413 |
|---|
Among these devices, 402 are declared implantable.
Devices declared under this manufacturer
- Ceramir Pediatric Crown 53/C Size S
- OCCLUSION VD 36 M
- OCCLUSION VD 36 S
- OCCLUSION VD SET 47-37 L LOW
- OCCLUSION VD SET 47-44 M low
- edelweiss CAD/CAM C-BLOCK A0 (10/12/16mm)
- edelweiss Nano Hybrid Composite A2
- edelweiss PEDIATRIC CROWN 62/ G Size S
- edelweiss PEDIATRIC CROWN 64/I Size XL
- edelweiss PEDIATRIC CROWN 74/L Size S
- edelweiss PEDIATRIC CROWN 84/S Size L
- edelweiss VENEER 14 L LONG
Showing 12 of 413 declared devices.
Catalogue references include 10169, 10221, 13160, 13195, 13230, 17048.
European nomenclature codes declared: Q01020502, Q010699, Q01010103, Q01010104.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EDELWEISS DENTISTRY PRODUCTS GMBH (AT) · FDA 3009117991 |
| Devices in EUDAMED | 413 |
| Country of registration | Austria |
Device-level evidence
| Devices with a numeric GTIN | 413 |
|---|---|
| Found in the U.S. device database | 338 |
| Share | 81.8 % |
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. edelweiss dentistry products gmbh is registered in the United States but was not found in the Canadian register.