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Flok Health Clinical Engine

by Flok Health Ltd EUDAMED

Active European Union

Ref Not ApplicableModel CELBP2

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberSCAR-6.2.1.5 Date20 Aug 2026IssuedStatusActive expires 6 Aug 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • SCAR-6.2.1.5 Active Amended

    Quality management system EU MDR

    Notified body
    3022
    Issued
    20 Aug 2026
    Expires
    6 Aug 2030
    Reason
    Other

Specification

EUDAMED

Model / Reference
CELBP2, Not Applicable
Primary DI / UDI-DI
05070002368328
Basic UDI-DI
50700023683CELBP1HY
EMDN Code
Z12069092 Various physiotherapy and rehabilitation instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000047133
Authorised representative
MedQAIR Services NL-AR-000048344

Other devices from Flok Health Ltd

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