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Vasseal

by Shanghai HeartCare Medical Technology Corporation Limited 2 variants

Ref VCD-VS-5F

Active European Union

CE MDR

Valid until

27 Aug 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR.2292-2026/0065 Date16 Oct 2026IssuedStatusActive expires 27 Aug 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR.2292-2026/0065 Active Amended

    Technical documentation EU MDR

    Certifier
    UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
    Issued
    16 Oct 2026
    Expires
    27 Aug 2031
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Vascular Closure Device
Model / Reference
VCD-VS-5F
Primary DI / UDI-DI
06971145486858
Basic UDI-DI
697114548VCDRL
EMDN Code
P07020299 Synthetic vascular patches - other
Device Class
Class III
EU market of registration
Türkiye

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.

  • Captor

    Class III

  • Sealsac

    Class III

  • Sealsac

    Class III

  • Sealsac

    Class III

  • Sealsac

    Class III

  • Sealsac

    Class III

See all devices from Shanghai Heartcare Medical Technology Co., Ltd. →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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