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Kit Consommable R-One

by Robocath S.A.S France EUDAMED

Ref RBH01C0000 EMDN Z12059085

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-RBH01C0000M4 Basic UDI-DIDate27 Oct 2021RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
R-One consumable kit
Model / Reference
RBH01C0000
Primary DI / UDI-DI
D-RBH01C0000M4, 03770024670226, 03770024670165
Basic UDI-DI
B-RBH01C0000M4, 3770024670RBH01C0000XS
EMDN Code
Z12059085 Various instruments for cardiology and cardiac surgery - consumables
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000003651

Other devices from Robocath S.A.S

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (3)

  • EUDAMED 12b1d4b8-a9a1-4cd9-91f1-1f023ead4d0d 61 fields · synced 24 Oct 2026
  • EUDAMED 03770024670226|3770024670RBH01C0000XS 61 fields · synced 17 May 2026
  • EUDAMED 03770024670165|3770024670RBH01C0000XS 61 fields · synced 17 May 2026