ADM, a.s.
CZ-MF-000032589 · Czechia · Brno
ADM, a.s. is registered in the European database on medical devices as a manufacturer, with 63 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 63 |
|---|
Among these devices, 47 are declared implantable.
Devices declared under this manufacturer
- Dentapreg® MESH Pink Sample
- Dentapreg® PFM Minirefill
- Dentapreg® PFU Sample
- Dentapreg® PFU Single
- Dentapreg® SFM Double Pack
- Dentapreg® SFM Refill
- Dentapreg® SFU Minirefill
- Dentapreg® SFU Reinforcement
- Dentapreg® SFU Sample Clin
- Dentapreg® UFM Refill
- Dentapreg® UFM Sample Clin
- Fibrafill® DENTIN
Showing 12 of 63 declared devices.
Catalogue references include D-005, D-053, D-204, D-301, D-514, D-523.
European nomenclature codes declared: Q010299, Q010199, Q01010199, Q010280, Q01010103, Q010105.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ADM, a.s. (CZ) · FDA 3005347791 |
| Devices in EUDAMED | 63 |
| Country of registration | Czechia |
Device-level evidence
| Devices with a numeric GTIN | 63 |
|---|---|
| Found in the U.S. device database | 19 |
| Share | 30.2 % |
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. ADM, a.s. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
25 0302 QR/NB | issued | 2030-07-30 |