Medikro Oy
FI-MF-000011841 · Finland · Kuopio
Medikro Oy is registered in the European database on medical devices as a manufacturer, with 51 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 51 |
|---|
Most frequent device types declared: M91227, M9242-WA, M9253, M9256-MM, M9256-WA.
Among these devices, 14 are declared active, 11 with a measuring function.
Devices declared under this manufacturer
- Disposable Flow Transducer
- Medikro Calibration Syringe Outlet Port Adapter Kit
- Medikro Calibration Syringe, volume 3000 ml
- Medikro Duo
- Medikro Grip
- Medikro Pressure Tube
- Medikro Primo
- Medikro Pro
- Medikro Spirometry Software
- Medikro® Ambi
- Pressure Tube with Grip
- SpiroSafe Disposable Flow Transducer
Showing 12 of 51 declared devices.
Catalogue references include 703418, M911-E, M91175, M91227, M9253-B-200, M9274.
European nomenclature codes declared: Z12150185, Z12150199, Z12150101, Z12150192.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDIKRO OY (FI) · FDA 3006895489 |
| Devices in EUDAMED | 51 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 27 |
|---|---|
| Found in the U.S. device database | 7 |
| Share | 25.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDIKRO OY |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2019-09-11 |
Licence types: System (2), Device Family (1).
Licensed under: DISPOSABLE FLOW TRANSDUCERS, CALIBRATION SYRINGE, MEDIKRO SPIROMETER.
North American profile: Both markets. Medikro Oy is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1056-876-25 | supplemented | 2030-05-09 |