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, 5514183, Centricity™ High Acuity Anesthesia 5.7, E-ENTROPY-01, E-NMT-01.
Among these devices, 163 are declared active, 82 with a measuring function.
Devices declared under this manufacturer
- CARESCAPE
- CARESCAPE RAD
- Carescape Dock F0
- Carescape Software
- F5-01
- Gas exhaust lines
- Patient Spirometry Tubes
- Portrait AAB01
- Portrait BCH01
- Portrait HSWXB
- Portrait HUBXB
- Portrait MMP01
Showing 12 of 306 declared devices.
Catalogue references include 2039040-005, 2039040-016, 2106394-004, E-NMT-01, E-sCOV-00, NA.
European nomenclature codes declared: Z1203020280, Z1203020285, Z1203020282, Z1203020201, Z1203020202, Z1203020292.
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 |
Device-level evidence
| Devices with a numeric GTIN | 305 |
|---|---|
| Found in the U.S. device database | 264 |
| Share | 86.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GE HEALTHCARE FINLAND OY |
What it holds in Canada
| Licences on record | 40 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 20 |
| Class 3 devices | 20 |
| First licensed | 2001-06-11 |
Licence types: Device Family (28), System (8), Single Device (3), Device Group Family (1).
Licensed under: PULSE OXIMETRY SENSORS AND CABLES, MOBILE CARE, PATIENT TUBE, POLYVINYL CHLORIDE (PVC), GAS SAMPLING LINES, ECG LEADS AND CABLES, NEURO MUSCULAR TRANSMISSION SENSORS/CABLES.
North American profile: Both markets. GE Healthcare Finland Oy is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1004-836-24 | supplemented | 2027-02-08 |