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Maximo® II CRT-D D264TRM

by Medtronic, Inc. EUDAMEDGUDID

Active European Union

Ref D264TRM

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-00613994714794 Basic UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00613994714794 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  • Withdrawn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 Active
  • 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 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Maximo® EUDAMED
Maximo® II CRT-D GUDID
Generic Name
Cardiac resynchronization therapy implantable defibrillator
Device Name
Maximo II CRT-D
Model / Reference
D264TRM
Primary DI / UDI-DI
00613994714794 EUDAMED
00613994714800 GUDID
Basic UDI-DI
B-00613994714794
FDA Product Code
NIK, KRG, LWS
EMDN Code
J01050301 Implantable triple chamber defibrillators, with sensors
GMDN Term
Cardiac resynchronization therapy implantable defibrillator
Device Class
Class AIMDD EUDAMED
Class III GUDID
Regulation Number
870.3700
Market of Registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00613994714794
GUDID
00613994714800
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