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Maximo® II DR D284DRG

by Medtronic, Inc. EUDAMEDGUDID

Withdrawn European Union

Ref D284DRG

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-00613994557667 Basic UDI-DIDate25 Aug 2026RegisteredStatusWithdrawn
European UnionCE/MDD EUDAMED NumberB-00613994557667 Basic UDI-DIDate25 Aug 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00613994557667 UDI-DIDate23 Sep 2014ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/AIMDD, CE/MDD Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Maximo® EUDAMED
Maximo® II DR GUDID
Generic Name
Dual-chamber implantable defibrillator
Device Name
Maximo II, Secura, Virtuoso ICD
Model / Reference
D284DRG
Primary DI / UDI-DI
00613994557667 EUDAMED
00613994446602 GUDID
Basic UDI-DI
B-00613994557667
FDA Product Code
NIK, LWS
EMDN Code
J01050201 Implantable dual chamber defibrillators, with sensors
GMDN Term
Dual-chamber implantable defibrillator
Device Class
Class AIMDD EUDAMED
Class III GUDID
Market of Registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00613994557667
GUDID
00613994446602
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