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SelectSecure™ MRI SureScan™

by Medtronic, Inc. 2 variants

Ref 383069

SelectSecure™ MRI SureScan™ (383069) is a device classified as Active implantable (AIMDD) made by Medtronic, Inc., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-00643169857711), active as of 7 Nov 2026.

Active European Union

CE AIMDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-00643169857711 Basic UDI-DI 00643169857711UDI-DIDate4 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/AIMDD Active

Specification

EUDAMED

Device name
SelectSecure Lead
Model / reference
383069
Primary DI / UDI-DI
00643169857711
Basic UDI-DI
B-00643169857711
EMDN code
J0190010102 Endocardial atrial and ventricular leads, bipolar (with active or passive fixation)
Device class
Class AIMDD
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands

Manufacturer details

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

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Other devices filed under PERMANENT PACEMAKER LEADS (WITH OR W/O STEROID-ELUTION).

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Properties

  • Supplied sterile
  • Implantable
  • Incorporates a medicinal substance
Other properties (11, all answered No)