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by Shanghai HeartCare Medical Technology Corporation Limited EUDAMED

Active European Union

Ref HC*TDE-3020Model HC*TDE-4020； HC*TDE-4040 ；HC*TDE-6020 ；HC*TDE-6030

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697114548TDERF Basic UDI-DIDate30 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • M.2023.MDR.1027-1 Withdrawn

    Technical documentation EU MDR

    Notified body
    UDEM Adriatic d.o.o. 2696
    Issued
    14 Nov 2023
    Expires
    13 Nov 2026
    Reason
    Other

Specification

EUDAMED

Device Name
Thrombectomy Device
Model / Reference
HC*TDE-4020； HC*TDE-4040 ；HC*TDE-6020 ；HC*TDE-6030, HC*TDE-3020
Primary DI / UDI-DI
06971145482072
Basic UDI-DI
697114548TDERF
EMDN Code
C010401020501 Manual cardiac thrombectomy and thromboaspiration systems
Device Class
Class III
Market of Registration
Croatia

Manufacturer details

EUDAMED SRN
CN-MF-000001941
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shanghai Heartcare Medical Technology Co., Ltd.

See all devices from Shanghai Heartcare Medical Technology 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