Micerium S.p.A.
IT-MF-000010187 · Italy · Avegno
Micerium S.p.A. is registered in the European database on medical devices as a manufacturer, with 3 088 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 3 088 |
|---|
Most frequent device types declared: Diamond Strips, Direct buccal tubes, Elastic ligature, Ena Post Fiber Post, Light Curing Composite 6a.
Devices declared under this manufacturer
- ENA / ENAMEL PLUS
- ENA MATRIX
- ENA MATRIX 3,5mm 50pcs
- Enamel Plus Shiny Strips
- Micerium Orthodontics Challenger
- Tender Fiber Zero
Showing 12 of 3 088 declared devices.
Catalogue references include ASLCDS1625S, BMK8R11, CP0212-1, CREF3, EILRB, TLDR2C16.
European nomenclature codes declared: Q01010103, Q010403, Q010401, Q010499, Q010402, Q010199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MICERIUM S.P.A. (IT) · FDA 3004130302 |
| Devices in EUDAMED | 3 088 |
| Country of registration | Italy |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MICERIUM S.P.A. |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 4 |
| First licensed | 2007-02-21 |
Licence types: Device Family (3), System (2), Device Group Family (1).
Licensed under: TENDER FIBER, ENA COMPOSITE RESTORATIVE MATERIAL, ENA TEMP(AESTHETIC TEMPORARY RESIN), ENA SHINY COMPOSITE FINISHING AND POLISHING SY, ENA BOND, AMCOP BIOACTIVATOR.
North American profile: Both markets. Micerium S.p.A. is registered in both the United States and Canada.