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EasyT

by SIS Medical AG 40 variants

Ref 300-020-134

Active European Union

CE MDR

Valid until

27 Feb 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier TÜV NORD CERT GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number44911221715 Date22 May 2026IssuedStatusActive expires 27 Feb 2030

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 44911221715 Active Supplemented

    Quality management system EU MDR

    Certifier
    TÜV NORD CERT GmbH 0044
    Issued
    22 May 2026
    Expires
    27 Feb 2030
    Reason
    Other
  • 44912221715 Active Amended

    Technical documentation EU MDR

    Certifier
    TÜV NORD CERT GmbH 0044
    Issued
    22 May 2026
    Expires
    27 Feb 2030
    Reason
    Mnf ar change

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
300-020-134
Primary DI / UDI-DI
07640142573586
Basic UDI-DI
764014257NIC_ETEM
Direct Marketing DI
07640142573586
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000015821
Authorised representative
EUMEDIQ GmbH DE-AR-000007809

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

Other devices from SIS Medical AG

  • Opn Nc 300-010-004

    Class II

  • Opn Nc 300-020-004

    Class II

  • EasyT

    Class III

  • NIC 1.1 hydro

    Class III

  • OPN NC PTCA Dilatation Catheter

    Class II

  • Opn Nc

    Class III

See all devices from SIS Medical AG →

Properties

  • Sterile

Other properties (12)

  • 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