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ArgusScout®

by Suzhou MicroPort Argus Medical Corp.

Ref Insight-100-1350

Active European Union

CE MDR

Valid until

17 Jan 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 753237 Date4 Aug 2026IssuedStatusActive expires 17 Jan 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 753237 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    4 Aug 2026
    Expires
    17 Jan 2029
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
ArgusScout® Sterile Imaging Catheter
Model / Reference
Insight-100-1350
Primary DI / UDI-DI
06971231030224
Basic UDI-DI
697123103NOPURGEVT
EMDN Code
C0104010101 Cardiac angiography diagnostic catheters
Device Class
Class III
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000027422
Authorised representative
MicroPort Medical B.V. NL-AR-000000166

Other devices from Suzhou MicroPort Argus Medical Corp

Properties

  • Sterile
  • Measuring Function

Other properties (11)

  • 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