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Extracalm

by Flen Health Pharma

Ref 1014-B

Active European Union

CE MDR CE MDD

Valid until

1 Nov 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

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 NumberB-05420013500482 Basic UDI-DIDate3 Sep 2026RegisteredStatusActive
European UnionCE/MDD NumberB-05420013500482 Basic UDI-DIDate3 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2253359CE03 Active

    Quality management system EU MDR

    Notified body
    DEKRA Certification B.V. 0344
    Issued
    3 Jun 2026
    Expires
    1 Nov 2027

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
Extracalm
Model / Reference
1014-B
Primary DI / UDI-DI
05420013500482
Basic UDI-DI
B-05420013500482, 5420013Extracalm01KL
EMDN Code
M04041503 Dressings in solutions, emulsions, gels, powders with synthetic components
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000258

Other devices from Flen Health Pharma

See all devices from Flen Health Pharma →

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