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Comp A.I.R. Pro NE-C900 (NE-C900-E)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref NE-C900-E
Identity
- Trade Name
- Comp A.I.R. Pro NE-C900 (NE-C900-E) EUDAMED
- Device Name
- Comp A.I.R. Pro NE-C900 EUDAMED
- Model / Reference
- NE-C900-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672106499 EUDAMED
- Basic UDI-DI
- 4015672106495S 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
Comp A.I.R. Pro NE-C900 (NE-C900-E) by OMRON Healthcare Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110860 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K141140 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4015672106495S | 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 (2)
- EUDAMED baa7c526-e38d-4dc4-93fe-771f654c2926 61 fields · synced Oct 5, 2026
- FDA 510(k) K110860 1 fields · synced May 18, 2026