Identity
- Trade Name
- EasyOne FlowTube (basic unit) EUDAMED
- Device Name
- Breathing mouthpieces EUDAMED
- Model / Reference
- 5050-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142190516 EUDAMED
- Basic UDI-DI
- 764014219mouthpiece24 EUDAMED
- EMDN Code
- Z12150185 SPIROMETRY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa 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 FlowTube (basic unit) 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 | 764014219mouthpiece24 | Class IIa | Active |
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Manufacturer
- Manufacturer
- NDD Medizintechnik AG
- EUDAMED SRN
- CH-MF-000015550
- Authorised Representative
- NDD Medizintechnik GmbH DE-AR-000032322
Sources (1)
- EUDAMED 03b558c8-9376-4b53-858b-e3e5e3a0bf05 61 fields · synced Jun 19, 2026