Skip to content

CapSureFix™ Novus

by Medtronic, Inc.

Ref 4076110

Active European Union

CE MDR

Valid until

1 Jul 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0763000B000068084 Basic UDI-DI 00763000686925UDI-DIDate27 Aug 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2250280TD06 Expiring Expires in 235 days

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 Jul 2022
    Expires
    1 Jul 2027

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
CAPSUREFIX® NOVUS MRI™ SureScan™
Model / reference
4076110
Primary DI / UDI-DI
00763000686925
Basic UDI-DI
0763000B000068084
EMDN code
J0190010102 Endocardial atrial and ventricular leads, bipolar (with active or passive fixation)
Device class
Class III
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000019977
Authorised representative
Medtronic B.V. NL-AR-000006050

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Implantable
  • Incorporates a medicinal substance

Other properties (11)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No