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AlwideTM Plus Balloon Catheter

by Shanghai MicroPort CardioFlow Medtech Co., Ltd. 11 variants

Ref BC-1640

Active European Union

CE MDR

Valid until

1 Apr 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification 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 Number6126688TD02 Date22 Oct 2025IssuedStatusActive expires 1 Aug 2030

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 6126688TD02 Active Amended

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    22 Oct 2025
    Expires
    1 Aug 2030
    Reason
    Mnf data change
  • 6126688CE01 Active Amended

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    15 Oct 2025
    Expires
    1 Apr 2029
    Reason
    Mnf data change

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Alwide Plus Balloon Catheter
Model / Reference
BC-1640
Primary DI / UDI-DI
06971493531897
Basic UDI-DI
697149353XT0007CE25
EMDN Code
C019014 Cardiac valvuloplasty catheters
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000002327
Authorised representative
MicroPort Medical B.V. NL-AR-000000166

Other devices from Shanghai MicroPort CardioFlow Medtech Co., Ltd.

See all devices from Shanghai MicroPort CardioFlow Medtech Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No