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REANIBEX-500IT EMS+Sp+MP+pP+ET

by Osatu Sociedad Cooperativa

Ref DIA0703E0000001Model Reanibex 300 / Reanibex 500

Active European Union

CE MDR

Valid until

26 Mar 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

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 Number1843604570E000000000002CS Basic UDI-DI 08436045705969UDI-DIDate19 May 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000291267 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    12 Feb 2026
    Expires
    26 Mar 2030
    Reason
    Other
  • 1000291268 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    18 Feb 2026
    Expires
    26 Mar 2030
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
AED/Manual Defibrillator Monitor Defibrillator
Model / Reference
Reanibex 300 / Reanibex 500, DIA0703E0000001
Primary DI / UDI-DI
08436045705969
Basic UDI-DI
1843604570E000000000002CS
Direct Marketing DI
08436045705969
EMDN Code
Z1203020202, Z1203020401, Z1203020408, Z12030501, Z12030502, Z12050301, Z12050302
Device Class
Class III
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
ES-MF-000004710

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Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No