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Adult Mask(SEBS) (NEB-MSLS-E)
EUDAMEDClass IIa (EU MDR)
Ref Adult Mask(SEBS) (NEB-MSLS-E)
Identity
- Trade Name
- Adult Mask(SEBS) (NEB-MSLS-E) EUDAMED
- Device Name
- Adult Mask EUDAMED
- Model / Reference
- Adult Mask(SEBS) (NEB-MSLS-E) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672102408 EUDAMED
- Basic UDI-DI
- 4015672102404L 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
Adult Mask(SEBS) (NEB-MSLS-E) 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 | 4015672102404L | 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 f4b607f7-2ed3-4503-b316-5bb197a2dd45 61 fields · synced Oct 6, 2026