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Scoreflex Trio

by OrbusNeich Medical (Shenzhen) Co., Ltd 24 variants

Ref 634001011

Active European Union

CE MDR

Valid until

24 May 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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/MDR NumberMDR 762468 Date18 Aug 2026IssuedStatusActive expires 24 May 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 762468 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    18 Aug 2026
    Expires
    24 May 2028
    Reason
    Change approved

Coverage

1 jurisdiction

Spain
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

  • Spain

Specification

EUDAMED

Device Name
Scoreflex TRIO Balloon Dilatation Catheter
Model / Reference
634001011
Primary DI / UDI-DI
06934955963223
Basic UDI-DI
69349559631ZH
Direct Marketing DI
06934955963223
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Spain

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 (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