CEFLA s.c.
IT-MF-000009228 · Italy · Imola
CEFLA s.c. is registered in the European database on medical devices as a manufacturer, with 410 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 139 |
|---|---|
| Class IIa | 271 |
Most frequent device types declared: Dental Units, Dental handpieces and contra-angles, Devices for recording X-ray imaging for intra oral images, Digital radiograpy sensors, Intraoral scanner.
Among these devices, 285 are declared active.
Devices declared under this manufacturer
- A-28 PLATINUM
- Goldspeed Evo R20-L
- Goldspeed Evo S1-L
- K 9.0
- NewTom VG-One
- S220 TR INTERNATIONAL
- S220 TR SIDE DELIVERY
- S4X-28
- X-3iO
- X-VS E
- X-ViSUS DCiS WL
- ZEN-X DCiS
Showing 12 of 410 declared devices.
Catalogue references include 701X0001, 701X0002, 701XB000, 71ZG0000, 76000571, 76000675, 7AA42xxx, 95520443, 95520662.
European nomenclature codes declared: Z12110101, Z12011305, Z11030480, Z1103030102, Z12110180, Z12119080.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CEFLA S.C. (IT) · FDA 3006610845 |
| Devices in EUDAMED | 410 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 410 |
|---|---|
| Found in the U.S. device database | 68 |
| Share | 16.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CEFLA S.C. |
North American profile: Both markets. CEFLA s.c. is registered in both the United States and Canada.