Ardo medical AG
CH-MF-000016526 · Switzerland · Unterägeri
Ardo medical AG is registered in the European database on medical devices as a manufacturer, with 108 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 108 |
|---|
Among these devices, 27 are declared sterile, 40 active.
Authorised representative in the Union: ARDO medical GmbH.
Devices declared under this manufacturer
- AMARYLL PLUS
- Alyssa & Bellis Double Pumpset D26
- Ardo Care Compresses
- Ardo Natal Support
- Brustglocke DeTach 14 mm (2 St.)
- Brustglocke DeTach 16 mm (2 St.)
- CALYPSO
- CARUM
- Double Pumpset plus
- Master
- OPTIFLOW
- Senator
Showing 12 of 108 declared devices.
Catalogue references include 30.00.37, 31.00.37, 31.00.38, 63.00.195, 63.00.284, 63.00.356.
European nomenclature codes declared: V020301, Z12080303, Z120105, Y090699, M040799, Z12080385.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ARDO MEDICAL AG (CH) · FDA 3003509351 |
| Devices in EUDAMED | 108 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 108 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 4.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ARDO MEDICAL AG |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2004-10-07 |
Licence types: System (3), Single Device (1).
Licensed under: SENATOR 30 POMPE D'ASPIRATION MEDICALE / SENAT, MASTER 45 POMPE D'ASPIRATION CHIRURGICALE / MA, CALYPSO, CARUM POWERED BREAST PUMP.
North American profile: Both markets. Ardo medical AG is registered in both the United States and Canada.