MicroPort CRM S.r.l.
IT-MF-000029013 · Italy · Saluggia (VC)
MicroPort CRM S.r.l. is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 12 |
|---|
Most frequent device types declared: Beflex RF46D, ECG cables, Esprit D, Esprit SR, HookUp Smart.
Among these devices, 22 are declared sterile, 22 implantable, 24 active.
Devices declared under this manufacturer
- Beflex RF46D
- Esprit D
- Esprit S
- Esprit SR
- HookUp Smart
- KORA 250 DR
- PLATINIUM 4LV CRT-D 1744
- PLATINIUM SonR CRT-D 1811
- PLATINIUM SonR CRT-D 1841
- RC013
- RC015
- RC019
Showing 12 of 34 declared devices.
Catalogue references include ICV1117, ICV1125, K379, RC015, RC019, RC032.
European nomenclature codes declared: Z12050403, J01050301, J01010302, J01010102, J0190010102, J01050101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MicroPort CRM S.r.l. (IT) · FDA 1000165971 |
| Devices in EUDAMED | 34 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 34 |
|---|---|
| Found in the U.S. device database | 7 |
| Share | 20.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MICROPORT CRM S.R.L. |
What it holds in Canada
| Licences on record | 28 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 14 |
| Class 3 devices | 1 |
| Class 4 devices | 13 |
| First licensed | 2002-02-14 |
Licence types: Device Group Family (8), System (7), Single Device (6), Device Family (4).
Licensed under: ORCHESTRA PROGRAMMER, SPIDERVIEW HOLTER ECG RECORDER, AMBULATORY HOLTER ANALYSIS SOFTWARE, PACEMAKERS ACCESSORY TOOLS, ORCHESTRA PLUS PROGRAMMER, REPLY RATE RESPONSIVE IMPLANTABLE PACEMAKERS.
North American profile: Both markets. MicroPort CRM S.r.l. is registered in both the United States and Canada.