Identity
- Trade Name
- EasyOne Mobile App EUDAMED
- Device Name
- Spirometry Software EUDAMED
- Model / Reference
- N/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142190912 EUDAMED
- Basic UDI-DI
- 764014219SpirometrySWYK EUDAMED
- Direct Marketing DI
- 07640142190912 EUDAMED
- EMDN Code
- Z12150182 SPIROMETRY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
EasyOne Mobile App by NDD Medizintechnik AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764014219SpirometrySWYK | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NDD Medizintechnik AG
- EUDAMED SRN
- CH-MF-000015550
- Authorised Representative
- NDD Medizintechnik GmbH DE-AR-000032322
Sources (1)
- EUDAMED 94066640-d4cd-4a3d-ad11-744b31a2331b 61 fields · synced Jul 15, 2026