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EasyT

by SIS Medical AG 40 variants

Part of a family of 47 devices: see the family page

Ref 300-025-134

EasyT (300-025-134) is a Class III device made by SIS Medical AG, registered in EUDAMED on 26 Mar 2025 (Basic UDI-DI 764014257NIC_ETEM) with CE/MDR certificate 44911221715 valid until 27 Feb 2030, active as of 22 Oct 2026.

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

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

Official records

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

Timeline

5 dated events

  1. Registered EUDAMED 764014257NIC_ETEM
  2. Certificate issued EUDAMED 44911221715
  3. Certificate issued EUDAMED 44912221715
  4. Certificate expires EUDAMED 44911221715
  5. Certificate expires EUDAMED 44912221715

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
300-025-134
Primary DI / UDI-DI
07640142573609
Basic UDI-DI
764014257NIC_ETEM
Direct marketing DI
07640142573609
EMDN code
C010401020101 Ptca balloon dilation catheters
Device class
Class III
EU registration type
Standard device
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

Similar devices in this category

Other devices filed under PTCA BALLOON DILATION CATHETERS.

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

See all devices from SIS Medical AG →

Properties

  • Supplied sterile
Other properties (13, all answered No)