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Cortisomol Sp

by Acteon Manufacturing

Ref 221606

Active European Union

CE MDR

Valid until

24 May 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier GMED SAS

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 Number40031 Date23 Jul 2026IssuedStatusActive expires 9 Oct 2029

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 40031 Active Supplemented

    Technical documentation EU MDR

    Certifier
    GMED SAS 0459
    Issued
    23 Jul 2026
    Expires
    9 Oct 2029
    Reason
    Other
  • 39305 Active Supplemented

    Quality management system EU MDR

    Certifier
    GMED SAS 0459
    Issued
    14 Jan 2026
    Expires
    24 May 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

IcelandEstoniaIrelandNetherlandsGermanyFranceBelgiumLuxembourgLiechtensteinAustriaBulgariaSpainCroatiaMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

EU market availability

Made available in 15 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 1 Apr 2025
  • Belgium since 1 Apr 2025
  • Bulgaria since 1 Apr 2025
  • Croatia since 1 Apr 2025
  • Cyprus since 1 Apr 2025
  • Estonia since 1 Apr 2025
  • France since 1 Apr 2025
  • Germany since 1 Apr 2025
  • Iceland since 1 Apr 2025
  • Ireland since 1 Apr 2025
  • Liechtenstein since 1 Apr 2025
  • Luxembourg since 1 Apr 2025
  • Malta since 1 Apr 2025
  • Netherlands since 1 Apr 2025
  • Spain since 1 Apr 2025

Last checked 31 Oct 2026.

Specification

EUDAMED

Model / Reference
221606
Primary DI / UDI-DI
03760243001062
Basic UDI-DI
376024300obturationL5
EMDN Code
Q01010202 Root canal filling dental cements
Device Class
Class III
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000007556

Other devices from Acteon Manufacturing

See all devices from Acteon Manufacturing →

Properties

  • Implantable
  • Incorporates Medicinal Product

Other properties (11)

  • Sterile: 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