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Sealsac

by Shanghai HeartCare Medical Technology Corporation Limited 97 variants

Ref ECS-1-2-HX-ESModel ECS-1-1-HX-ES

Active European Union

CE MDR

Valid until

29 Sep 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR.2292-2026-0081 Date9 Oct 2026IssuedStatusActive expires 29 Sep 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR.2292-2026-0081 Active

    Technical documentation EU MDR

    Certifier
    UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
    Issued
    9 Oct 2026
    Expires
    29 Sep 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Embolization Coil System
Model / Reference
ECS-1-1-HX-ES, ECS-1-2-HX-ES
Primary DI / UDI-DI
06971145487091
Basic UDI-DI
697114548ECS-2D-ESZ6
EMDN Code
C010402020301 Embolisation coils
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