Identity
- Trade Name
- LUMIS 150 VPAP ST-A FR CO EUDAMED
- Device Name
- Lumis 150 VPAP ST-A , Lumis 100 VPAP ST-A EUDAMED
- Model / Reference
- 28216 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00619498282166 EUDAMED
- Basic UDI-DI
- 619498EC1676V EUDAMED
- Direct Marketing DI
- 00619498285150 EUDAMED
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lumis 150 Vpap St-A Fr Co by Resmed Pty 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 | K113288 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K080131 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 619498EC1676V | Class IIa | Active |
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Manufacturer
- Manufacturer
- ResMed PTY LTD
- EUDAMED SRN
- AU-MF-000011753
- Authorised Representative
- ResMed SAS FR-AR-000007151
Sources (2)
- EUDAMED a9e2f15c-6963-4e1c-8256-5234e8ca360c 61 fields · synced Jul 28, 2026
- FDA 510(k) K113288 1 fields · synced May 18, 2026