Vitalograph (Ireland) Limited
IE-MF-000004858 · Ireland · Ennis, Co. Clare
Vitalograph (Ireland) Limited is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 9 |
|---|
Most frequent device types declared: 2020, 2030, 2040, 9100, 9160.
Among these devices, 4 are declared active, 3 with a measuring function.
Catalogue references include 20232, 20303, 20392, 20408, 36020, 91510.
European nomenclature codes declared: R9099, Z12159003, Z12159080, Z12159007.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | VITALOGRAPH IRELAND LTD. (IE) · FDA 3002808458 |
| Devices in EUDAMED | 9 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 8 |
| Share | 88.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | VITALOGRAPH (IRELAND) LTD |
What it holds in Canada
| Licences on record | 14 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 14 |
| First licensed | 2005-06-14 |
Licence types: Device Family (10), Single Device (3), Device Group Family (1).
Licensed under: 4300 PEAK FLOW METER, VITALOGRAPH ASMA-1 ELECTRONIC ASTHMA MONITOR, VITALOGRAPH MODEL 6800 PNEUMOTRAC, VITALOGRAPH MODEL 6600, VITALOGRAPH MODEL 6000, VITALOGRAPH MODEL 2120.
North American profile: Both markets. Vitalograph (Ireland) Limited is registered in both the United States and Canada.