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Inhalation mask set (NEB-MSILS-78E)
EUDAMEDClass IIa (EU MDR)
Ref NEB-MSILS-78E
Identity
- Trade Name
- Inhalation mask set (NEB-MSILS-78E) EUDAMED
- Device Name
- Inhalation mask set EUDAMED
- Model / Reference
- NEB-MSILS-78E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672109919 EUDAMED
- Basic UDI-DI
- 40156721099168 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
Inhalation mask set (NEB-MSILS-78E) by OMRON Healthcare Co., Ltd. — 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 | 40156721099168 | 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 a81db408-0a39-4d8e-bc63-b5f54ec09870 61 fields · synced Jun 19, 2026