AirLife Finland Oy
FI-MF-000001482 · Finland · Helsinki
AirLife Finland Oy is registered in the European database on medical devices as a manufacturer, with 1 081 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 081 |
|---|
Most frequent device types declared: 300 Series ECG Leadwires, ECG Leadwires for KISS System, Invasive Blood Pressure Cables, Multi-Link ECG Care Cables, Multi-Link ECG leadwires.
Among these devices, 2 are declared sterile, 6 reusable, 6 active, 9 with a measuring function.
Devices declared under this manufacturer
- Medisorb™ Multi-Absorber Original, Disposable
- Multi-LinkTM X2 ECG Reusable Trunk Cable 6-Lead for GE, IEC, 23 cm/ 9
- Multi-Link™ ECG Leadwire, Replaceable Set, 5-lead, Grabber, AHA, 130 c
- Multi-Link™ X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwir
- Vital Signs™ 300-Series ECG Leadwire, 3-lead, Snap, AHA, 75 cm/ 30 in
- Vital Signs™ 300-Series ECG Leadwire, 5-lead, Grabber, AHA, 125 cm/ 49
- Vital Signs™ Breathing Circuit, Corrugated, Adult, Disposable, 2.4m/ 9
- Vital Signs™ Breathing Circuit, Pediatric, Corrugated, Disposable, 2.4
- Vital Signs™ Breathing Circuit, Pediatric, Disposable, 1.8 m/72 in
- Vital Signs™ Cable for CAM14 for MAC5500™, 1.3 m/4.2 ft
- Vital Signs™ Leadwire NST for KISS™ System
- Vital Signs™ Manual Ventilation Tube for ABS Bag Arm, Expandable, Disp
Showing 12 of 1 081 declared devices.
Catalogue references include 2066479-010, 2066480-026, 2090200-043, 545318, 545327-HEL, M1052086.
European nomenclature codes declared: Z12050380, Z12050385, R02010101, Z1203020485, R040102, R020102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AirLife Finland Oy (FI) · FDA 3010838917 |
| Devices in EUDAMED | 1 081 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 1 076 |
|---|---|
| Found in the U.S. device database | 974 |
| Share | 90.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AIRLIFE FINLAND OY |
What it holds in Canada
| Licences on record | 56 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 56 |
| First licensed | 2016-01-21 |
Licence types: Device Family (34), Single Device (17), Device Group Family (4), System (1).
Licensed under: VITAL SIGNS INVASIVE BLOOD PRESSURE CABLES, HEAT AND MOISTURE EXCHANGERS WITH INTEGRATED B, VITAL SIGNS ANESTHESIA GAS SAMPLING LINE, DISP, MEDISORB DUST FILTER FOR REUSABLE MULTI-ABSORB, VITAL SIGNS TEMPERATURE CABLE FOR GE MONITORS,, VITAL SIGNS TEMPERATURE CABLE FOR GE MONITORS,.
North American profile: Both markets. AirLife Finland Oy is registered in both the United States and Canada.