Skip to content

Isolator Linear Pen

by AtriCure, Inc.

Ref MLP1/A000318-4Model MLP1/MCR1/MAX3/MAX5

Isolator Linear Pen (MLP1/A000318-4) is a Class III device made by Atricure, Inc., registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 08401439000000000000018ZU) with CE/MDR certificate MDR 754861 valid until 16 Dec 2029, active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

16 Dec 2029

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08401439000000000000018ZU Basic UDI-DI 10840143910937UDI-DIDate2 Jul 2026RegisteredStatusActive

Official records

  • EUDAMED public site Basic UDI-DI 08401439000000000000018ZU — open Devices and search for it

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 754861 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    26 Aug 2025
    Expires
    16 Dec 2029
    Reason
    Other

Timeline

3 dated events

  1. Certificate issued EUDAMED MDR 754861
  2. Registered EUDAMED 08401439000000000000018ZU
  3. Certificate expires EUDAMED MDR 754861

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Pens
Model / reference
MLP1/MCR1/MAX3/MAX5, MLP1/A000318-4
Primary DI / UDI-DI
10840143910937
Basic UDI-DI
08401439000000000000018ZU
EMDN code
C020301 Arrhythmogenic foci radiofrequency ablation catheters
Device class
Class III
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
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
Other properties (12, all answered No)