GE Healthcare Finland Oy
FI-MF-000001176 · Finland · HELSINKI
GE Healthcare Finland Oy is registered in the European database on medical devices as a manufacturer, with 306 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 178 |
|---|---|
| Class IIb | 128 |
Most frequent device types declared: 2103966-001, E-NMT-01, Version 3 (build 3.2), E-ENTROPY-01, V2.4.
Among these devices, 163 are declared active, 82 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GE HEALTHCARE FINLAND OY (FI) · FDA 9610105 |
| Devices in EUDAMED | 306 |
| Country of registration | Finland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1004-836-24 | supplemented | 2027-02-08 |