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Visia AF MRI™ S VR SureScan™ DVFC3D4

by Medtronic, Inc.

Ref DVFC3D4

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD CE AIMDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-00643169720817 Basic UDI-DI Date26 Aug 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-00643169720817 Basic UDI-DI Date26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00643169720817 UDI-DI Date25 Sep 2017ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/AIMDD, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Visia AF MRI™ S VR SureScan™
Generic Name
Single-chamber implantable defibrillator
Device Name
Evera,Visia AF, Primo/Mirro w MRI
Model / Reference
DVFC3D4
Primary DI / UDI-DI
00643169720817 EUDAMED
00763000206352 EUDAMED
00643169672789 EUDAMED
00643169566453 EUDAMED
00643169988651 GUDID
Basic UDI-DI
B-00643169720817, B-00763000206352, B-00643169672789, B-00643169566453
FDA Product Code
NVZ, LWS
EMDN Code
J01050101 Implantable single chamber defibrillators, with sensors
GMDN Term
Single-chamber implantable defibrillator
Device Class
Class AIMDD EUDAMED
Class III GUDID
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00643169720817
00763000206352
00643169672789
00643169566453
GUDID
00643169988651
Device ClassEUDAMED
Class AIMDD
GUDID
Class III

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number

Other properties (19)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No