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OctPlus

by Shanghai Pulse Medical Technology, Inc. China EUDAMED

Ref NAModel OctPlus

EMDN Z129092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697468773OCT01UA Basic UDI-DIDate15 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
OCT-Derived Fractional Flow Reserve Analysis Software
Model / Reference
OctPlus, NA
Primary DI / UDI-DI
06974687731226
Basic UDI-DI
697468773OCT01UA
Direct Marketing DI
06974687731226
EMDN Code
Z129092 Various instruments for functional exploration and therapeutic interventions - medical device software
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000033837
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shanghai Pulse Medical Technology, Inc.

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED dbb70323-e58c-46fd-bdf6-4d1fc68d24f6 61 fields · synced 22 Oct 2026