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SofTIP

by AtriCure, Inc.

Ref SofTIP13/A001335-1

SofTIP (SofTIP13/A001335-1) is a Class III device made by Atricure, Inc., registered in EUDAMED on 28 Jun 2026 (Basic UDI-DI 08401439000000000000002ZD) with CE/MDR certificate MDR 752587 valid until 24 Jul 2028, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

24 Jul 2028

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

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08401439000000000000002ZD Basic UDI-DI 10840143909672UDI-DIDate28 Jun 2026RegisteredStatusActive

Official records

  • EUDAMED public site Basic UDI-DI 08401439000000000000002ZD — open Devices and search for it

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 752587 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    11 Aug 2025
    Expires
    24 Jul 2028
    Reason
    Other

Timeline

3 dated events

  1. Certificate issued EUDAMED MDR 752587
  2. Registered EUDAMED 08401439000000000000002ZD
  3. Certificate expires EUDAMED MDR 752587

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
LARIAT Placement Devices
Model / reference
SofTIP13/A001335-1
Primary DI / UDI-DI
10840143909672
Basic UDI-DI
08401439000000000000002ZD
EMDN code
C0599 Cardiovascular introducer sheaths - other
Device class
Class III
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000002974
Authorised representative
AtriCure Europe B.V. NL-AR-000000165

Other devices from Atricure, Inc.

See all devices from Atricure, Inc. →

Properties

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