Skip to content

GENOSS PTCA Balloon Catheter

by GENOSS Co., Ltd. 87 variants

Ref GBC-10-250Model GBC-15-250

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809324761183 Basic UDI-DI 08809324761183UDI-DIDate29 Jun 2026RegisteredStatusActive

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

Spain
  • 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  • Withdrawn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.

  • Spain since 1 Jul 2026

Last checked 27 Oct 2026.

Specification

EUDAMED

Model / Reference
GBC-15-250, GBC-10-250
Primary DI / UDI-DI
08809324761183
Basic UDI-DI
B-08809324761183
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000029064
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Genoss

See all devices from Genoss →

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