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Scoreflex NC

by OrbusNeich Medical (Shenzhen) Co., Ltd 12 variants

Ref 617-154-1J

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-06934955936029 Basic UDI-DI 06934955936029UDI-DIDate23 Dec 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Italy
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

EU market availability

Made available in 1 country, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Italy since 1 Dec 2020

Last checked 2 Nov 2026.

Specification

EUDAMED

Device Name
Scoreflex NC Coronary Dilatation Catheter
Model / Reference
617-154-1J
Primary DI / UDI-DI
06934955936029
Basic UDI-DI
B-06934955936029
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU 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

  • 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