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Dualpro™ IVUS+NIRS Imaging Catheter

by Nipro Vascular Innovations Americas, Inc. EUDAMEDGUDID

Active European Union and United States

Ref TVC-C195-42

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 766211 Date7 Aug 2026IssuedStatusActive expires 19 Dec 2027
United StatesGUDID listing GUDID Number00857595006234 UDI-DIDate25 Nov 2024ListedStatusIn distribution
European UnionCE/MDD EUDAMED NumberB-00857595006234 Basic UDI-DIDate11 Apr 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 766211 Amended

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    7 Aug 2026
    Expires
    19 Dec 2027
    Reason
    Mnf data change

Specification

EUDAMED · GUDID

Trade Name
Dualpro™ IVUS+NIRS Imaging Catheter EUDAMED
Dualpro IVUS+NIRS Imaging Catheter EUDAMED
Dualpro™ IVUS+NIRS Imaging Catheter Kit GUDID
Generic Name
Intravascular ultrasound imaging catheter, single-use
Model / Ref / Catalog
TVC-C195-42
Primary DI / UDI-DI
00857595006234, 00857595006494, 00857595006852, 00857595006821, 00857595006791, 00857595006760
Basic UDI-DI
B-00857595006234, 0857595006CNUC8
FDA Product Code
IYO, OGZ
EMDN Code
C0104010102 Cardiac and intracoronary ultrasound catheters
GMDN Term
Intravascular ultrasound imaging catheter, single-use
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
892.1560, 870.1200
Market of Registration
Czechia
Belgium
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000002341
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Sterile
  • Single Use
  • Measuring Function
  • Prescription Use
  • Convenience Kit NoGUDIDYesGUDID
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No