NDD Medizintechnik AG
CH-MF-000015550 · Switzerland · Zürich
NDD Medizintechnik AG is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 35 |
|---|
Among these devices, 8 are declared active, 8 with a measuring function.
Authorised representative in the Union: NDD Medizintechnik GmbH.
Devices declared under this manufacturer
- DLCO Barriette (100 pcs)
- DLCO Barriette (50 pcs)
- Easy on-PC
- Easy on-PC flow sensor / Spiroson-AS
- EasyOne Air
- EasyOne Filter FT, 100 pcs
- EasyOne Filter FT, single packaged
- EasyOne Filter SP, single packaged
- EasyOne FlowTube, box of 200 pcs.
- EasyOne FlowTube, box of 500 pcs.
- EasyOne Sky
- Spirette FA Pro/LAB, 50 pcs box
Showing 12 of 35 declared devices.
Catalogue references include 2050-71, 2091-41, 2500-2, 2700-1SP, 2700-3, 2800-1.
European nomenclature codes declared: Z12150185, Z12150180, Z12150182, Z12150101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NDD MEDIZINTECHNIK AG (CH) · FDA 9614485 |
| Devices in EUDAMED | 35 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 35 |
|---|---|
| Found in the U.S. device database | 19 |
| Share | 54.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NDD MEDIZINTECHNIK AG |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2009-01-09 |
Licence types: Device Group (2), Single Device (1), System (1).
Licensed under: EASY ON-PC SYSTEM, EASYONE PRO RESPIRATORY ANALYSIS SYSTEM, EASYONE PRO LAB, EASYONE AIR SPIROMETY SYSTEM.
North American profile: Both markets. NDD Medizintechnik AG is registered in both the United States and Canada.