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Excalibur Sport PFM + BPM + SpO2

by Lode B.V. EUDAMED

Active European Union

Ref 965920SB

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number871752464965920SBZW Basic UDI-DIDate20 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2246826CE01 Supplemented Expires in 67 days

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    25 Mar 2022
    Expires
    1 Jan 2027
    Reason
    Add device or group

Specification

EUDAMED

Device Name
Excalibur Sport PFM with BPM and SpO2
Model / Reference
965920SB
Primary DI / UDI-DI
87175246412388
Basic UDI-DI
871752464965920SBZW
Direct Marketing DI
87175246412388
EMDN Code
Z12050101 Stress analysis systems
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000001493

Other devices from Lode B.V.

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Properties

Show 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