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Truevision

by Insight Lifetech Co., Ltd. 2 variants

Ref 02-5F60-02Model 02-6F40-02; 02-6F60-02

Active European Union

CE MDR

Valid until

10 Mar 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

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

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 786854 Date16 Dec 2025IssuedStatusActive expires 10 Mar 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 786854 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    16 Dec 2025
    Expires
    10 Mar 2029
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
TRUEVISION Intravascular Ultrasound Imaging Catheter
Model / Reference
02-6F40-02, 02-6F60-02, 02-5F60-02
Primary DI / UDI-DI
06971318442155
Basic UDI-DI
697131844002C87
EMDN Code
C0104010102 Cardiac and intracoronary ultrasound catheters
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000011205
Authorised representative
MedNet EC-REP C III GmbH DE-AR-000011196

Other devices from Insight Lifetech Co., Ltd.

Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No