Identity
- Trade Name
- Lumis 100 VPAP ST UK/EUR2 EUDAMED
- Device Name
- Lumis 100 VPAP S , Lumis 100 VPAP ST , Lumis 150 VPAP ST EUDAMED
- Model / Reference
- 28104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00619498281046 EUDAMED
- Basic UDI-DI
- 619498EC1616H EUDAMED
- Direct Marketing DI
- 00619498285044 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 100 VPAP ST UK/EUR2 by Resmed Pty 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 | 619498EC1616H | 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 (1)
- EUDAMED 47fdb010-7b34-49c2-bf93-3de7ea24e891 61 fields · synced Jul 11, 2026