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Dosivent

by Reiner Medtech S.L.U 4 variants

Ref 00540EAM000, 00540EAZ050, 00540EAZ000, 00540EAZ010, 00540ENA030, 00540EAZ030, 00540ENA010, 00540EAM030, 00540ENA000Model Dosivent

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437028850CIM1000000110HU Basic UDI-DI Date16 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Camara Anti Estatica Para La Inhalacion De Aerosol Con Mascarilla
Model / Reference
Dosivent, 00540EAM000, 00540EAZ050, 00540EAZ000, 00540EAZ010, 00540ENA030, 00540EAZ030, 00540ENA010, 00540EAM030, 00540ENA000
Primary DI / UDI-DI
08437028850058, 08437028850188, 08437028850065, 08437028850102, 08437028850126, 08437028850140, 08437028850089, 08437028850133, 08437028850041
Basic UDI-DI
8437028850CIM1000000110HU
EMDN Code
Z12159002 Aerosol equipment
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000048477

Other devices from Reiner Medtech S.L.U

See all devices from Reiner Medtech S.L.U →

Properties

Other properties (13)

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