ab medica spa
IT-MF-000029717 · Italy · Milano
ab medica spa is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|
Among these devices, 3 are declared sterile.
Devices declared under this manufacturer
- CAREPAD
- DOLPHIN
- Dolphin
- PIATTAFORMA TELEMEDICINA
- Robotic Tray
Catalogue references include ABMAIACONCARE, DPH-KC0533G, DPH-KC0545G, DPH-KSCG, PAD90503, RPT-5.
European nomenclature codes declared: K01020199, Z12011285, Z12040192, S0199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AB MEDICA SAS (FR) · FDA 3011221476 |
| Devices in EUDAMED | 6 |
| Country of registration | Italy |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AB MEDICA SAS |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2024-05-15 |
Licence types: System (3), Device Family (1).
Licensed under: TROCAR INSTRUMENT, BIPOLAR LAPAROSCOPIC FORCEPS, MONOPOLAR INSTRUMENTS AND HAND INSTRUMENTS, RIGID ENDOSCOPES AND ACCESSORIES.
North American profile: Both markets. ab medica spa is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030088-00 | issued | 2029-07-30 |