Icare Finland Oy
FI-MF-000000501 · Finland · Vantaa
Icare Finland Oy is registered in the European database on medical devices as a manufacturer, with 49 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 49 |
|---|
Most frequent device types declared: RSP01, TA023, TA031, TA032, TP01.
Among these devices, 4 are declared sterile, 34 active, 21 with a measuring function.
Devices declared under this manufacturer
- IC1000 ChargingCradle
- IC1000 SmartCradle
- ST500 Remote
- Ventica Analytics
- iCare EXPORT
- iCare HOME
- iCare HOME2
- iCare IC100
- iCare IC1000
- iCare IC200
- iCare PATIENT2
- iCare TP01 Probes
Showing 12 of 49 declared devices.
Catalogue references include 107, 260A2, 690, 691, RSP01, Standard A1.
European nomenclature codes declared: Z12120122, Z12120185, Z12120182, Z12159099, Z12129080, Z12159092.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Icare Finland Oy (FI) · FDA 3005324856 |
| Devices in EUDAMED | 49 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 49 |
|---|---|
| Found in the U.S. device database | 11 |
| Share | 22.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ICARE FINLAND OY |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| First licensed | 2016-06-01 |
Licence types: System (4), Single Device (1).
Licensed under: ICARE IC100, ICARE IC200, ICARE HOME2, ICARE ST500, ICARE IC1000.
North American profile: Both markets. Icare Finland Oy is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI22/00000011 | supplemented | 2027-10-09 |
FI22/00000011 | reissued | 2030-10-06 |