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Introducer Set

by Shanghai INT Medical Instruments Co., Ltd. China EUDAMED

Ref BFS14Model 4F, 5F, 6F, 7F, 8F

EMDN C0504

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69509009CEIKRW Basic UDI-DIDate24 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Introducer Set
Model / Reference
4F, 5F, 6F, 7F, 8F, BFS14
Primary DI / UDI-DI
06950900906398
Basic UDI-DI
69509009CEIKRW
EMDN Code
C0504 Arterial introduction sets
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009966
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shanghai INT Medical Instruments Co., Ltd.

See all devices from Shanghai INT Medical Instruments Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 015e9130-3371-4f9e-ae8c-c27adbd08499 61 fields · synced 24 Oct 2026