Identity
- Trade Name
- Mouthpiece set (NEB-MPSS-78E) EUDAMED
- Device Name
- Mouthpiece set EUDAMED
- Model / Reference
- NEB-MPSS-78E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672109940 EUDAMED
- Basic UDI-DI
- 4015672109946E EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
A mouthpiece set, specifically designed for the administration of a particular medical product. This device provides a sterile environment for the insertion and removal of instruments, ensuring effective patient care. With its advanced features and robust design, it is an ideal solution for various clinical applications.
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 | 4015672109946E | Class IIa | Active |
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Manufacturer
- Manufacturer
- OMRON Healthcare Co., Ltd.
- EUDAMED SRN
- JP-MF-000007213
- Authorised Representative
- OMRON Healthcare Europe B.V. NL-AR-000002683
Sources (1)
- EUDAMED aaaacb7c-0bb4-4857-89b2-0b27c0c4e398 61 fields · synced Jul 7, 2026