Amann Girrbach AG
AT-MF-000000252 · Austria · Mäder
Amann Girrbach AG is registered in the European database on medical devices as a manufacturer, with 810 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 810 |
|---|
Among these devices, 777 are declared implantable.
Devices declared under this manufacturer
- Ceramill Sintron 98x14 F
- Ceramill Zolid HT+ PS A1 98x14
- Ceramill Zolid HT+ PS A3,5 98x20 F
- Ceramill Zolid HT+ white 98x12
- Zolid Bion BL1 98x18 F
- Zolid DRS C1 B40 UN
- Zolid Gen-X BL1 98x18 F
- Zolid Gen-X BL1 98x25 F
- Zolid Lunaris A1 98x18
- Zolid Lunaris A4 98x18
- Zolid Naturals Opacifier
- Zolid gen-x A3 98x25
Showing 12 of 810 declared devices.
Catalogue references include 766159, 766841, 766857, 766877, 767519, 767694.
European nomenclature codes declared: Q010699, Q010601, L159099, L15900699, Q010280, Q010207.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Amann Girrbach AG (AT) · FDA 3030515618 |
| Devices in EUDAMED | 810 |
| Country of registration | Austria |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AMANN GIRRBACH AG |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 3 |
| First licensed | 2010-06-24 |
Licence types: Device Family (3), System (2).
Licensed under: CERAMILL SINTRON, CERAMILL ZOLID FX, CERAMILL A-SPLINT, CERAMILL A-TEMP, ZOLID LUNARIS.
North American profile: Both markets. Amann Girrbach AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 019612 0085 Rev. 00 | issued | 2031-06-07 |
G10 019612 0068 | issued | 2026-06-07 |