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Solventum™ Tegaderm™

by Solventum US LLC 2 variants

Ref 9124

Active European Union

CE MDR

Valid until

29 Jan 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 811476 Date11 Sep 2026IssuedStatusActive expires 29 Jan 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 811476 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    11 Sep 2026
    Expires
    29 Jan 2030
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Solventum™ Tegaderm™ Antimicrobial Transparent Dressing Solventum™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing
Model / Reference
9124
Primary DI / UDI-DI
00197998173516
Basic UDI-DI
01979988401010000000235MY
EMDN Code
M040412 Antiseptics-based dressings
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000044314
Authorised representative
Solventum Germany GmbH DE-AR-000043541

Other devices from Solventum US LLC

See all devices from Solventum US LLC →

Properties

  • Sterile
  • Incorporates Medicinal Product

Other properties (11)

  • 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