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Sealsac

by Shanghai HeartCare Medical Technology Corporation Limited China EUDAMED

Ref ECS-8-30-3D-STDModel ECS-4-6-HX-SS

EMDN C010402020301

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

TürkiyeTürkiyeTürkiyeTürkiyeTürkiyeTürkiye
  • Active
  • Not covered

European Union — CE/MDR Active

EU market availability

Available in 1 country, as listed in EUDAMED:

  • Türkiye

Last checked 23 Oct 2026.

Certificates

1 certificate · EUDAMED

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

    Technical documentation EU MDR

    Notified body
    Notified body 2292
    Issued
    9 Oct 2026
    Expires
    29 Sep 2031

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Embolization Coil System
Model / Reference
ECS-4-6-HX-SS, ECS-8-30-3D-STD
Primary DI / UDI-DI
06971145487725
Basic UDI-DI
697114548ECSPV
EMDN Code
C010402020301 Embolisation coils
Device Class
Class III
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 Corporation Limited

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See all devices from Shanghai HeartCare Medical Technology Corporation Limited →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06971145487725|697114548ECSPV 61 fields · synced 22 Oct 2026