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Scoreflex NC

by OrbusNeich Medical (Shenzhen) Co., Ltd China EUDAMED

Ref 635-104-1J

EMDN C010401020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06934955936197 Basic UDI-DIDate23 Dec 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Scoreflex NC Coronary Dilatation Catheter
Model / Reference
635-104-1J
Primary DI / UDI-DI
06934955936197
Basic UDI-DI
B-06934955936197
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000011345
Authorised representative
Quality First International OÜ EE-AR-000004308

Other devices from OrbusNeich Medical (Shenzhen) Co., Ltd

See all devices from OrbusNeich Medical (Shenzhen) Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED b2d5c44f-da44-46ef-b58a-986d69cccf78 61 fields · synced 24 Oct 2026