MIR - Medical International Research S.p.A.
IT-MF-000014026 · Italy · Rome
MIR - Medical International Research S.p.A. is registered in the European database on medical devices as a manufacturer, with 71 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 71 |
|---|
Most frequent device types declared: MIR040, MIR053, MIR065, MIR066 Accessories, MIR080.
Among these devices, 45 are declared active.
Devices declared under this manufacturer
- Cardionica Patch
- FlowMIR Disposable Turbine
- MIR Super SDK Mac
- MIR Super SDK iOS
- Minispir
- Minispir Plus
- Nuvoair Disposable Turbine
- Reusable Turbine PLUS
- Smart One
- Spirobank II Light
- Spirobank Smart
- Spirodoc
Showing 12 of 71 declared devices.
Catalogue references include 910004, 910606 - 910606E - 910606I, 911006 - 911006T - 911006E0 - 911006E1 - 911006I0 - 911006I1, 911081E5, 91110051 - 91110050, 91111051.
European nomenclature codes declared: Z12150102, Z12150180, Z12150192, C020501, Z1203020408, Z12050301.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A. (IT) · FDA 9614860 |
| Devices in EUDAMED | 71 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 71 |
|---|---|
| Found in the U.S. device database | 36 |
| Share | 50.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A. |
What it holds in Canada
| Licences on record | 9 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| Class 3 devices | 1 |
| First licensed | 2006-04-27 |
Licence types: Device Family (4), Single Device (3), Device Group Family (1), System (1).
Licensed under: SPIROMETERS, MIR SPIROMETER - OXIMETER, SMART ONE, MIR SPIROMETER - OXIMETER, FLOWMIR DISPOSABLE TURBINE WITH CARDBOARD MOUT, FLOWMIR PLUS DISPOSABLE TURBINE.
North American profile: Both markets. MIR - Medical International Research S.p.A. is registered in both the United States and Canada.