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Lumis 100/150 VPAP ST-A, AirCurve 10 ST-A

by ResMed PTY LTD 3 variants

Ref 28231

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number619498EC1676V Basic UDI-DI 00619498282319UDI-DIDate29 Apr 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Lumis 150 VPAP ST-A, Lumis 100 VPAP ST-A
Model / Reference
28231
Primary DI / UDI-DI
00619498282319
Basic UDI-DI
619498EC1676V
Direct Marketing DI
00619498285327
EMDN Code
Z1203010504 Adult and paediatric/neonatal pulmonary ventilators
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
AU-MF-000011753
Authorised representative
ResMed SAS FR-AR-000007151

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Properties

  • CMR Substance
  • Administering Medicine

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No