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Peripheral Guiding Catheter

by Shanghai INT Medical Instruments Co., Ltd.

Ref EBU, GCEBU305FModel EBU,RBU,ECR,HS,MP,IM,SCR,SBS,XB,STR,HI, 5F, 6F, 7F, 8F

Active European Union

CE MDR 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-GuidingCatheter3Y Basic UDI-DI Date25 Mar 2025RegisteredStatusActive
European UnionCE/MDD NumberB-GuidingCatheter3Y Basic UDI-DI Date25 Mar 2025RegisteredStatusActive

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

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
Guiding Catheter
Model / Reference
EBU, RBU, ECR, HS, MP, IM, SCR, SBS, XB, STR, HI, 5F, 6F, 7F, 8F, GCEBU305F
Primary DI / UDI-DI
D-GuidingCatheter3Y, 06950900937033
Basic UDI-DI
B-GuidingCatheter3Y, 69509009CEGCR8
EMDN Code
C0104020204 Peripheral angiography guide catheters
Device Class
Class IIa
EU 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

  • 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