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Tubing Flowsensors

by Transonic Systems Inc. United States EUDAMED

Ref HS2XLModel Flowsensors EMDN Z12040111

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number087746600HQHSSELE Basic UDI-DIDate18 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Flowsensors
Model / Reference
Flowsensors, HS2XL
Primary DI / UDI-DI
00877466007672
Basic UDI-DI
087746600HQHSSELE
EMDN Code
Z12040111 Blood flow meters
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000008784
Authorised representative
Transonic Europe BV NL-AR-000004627

Other devices from Transonic Systems Inc.

See all devices from Transonic Systems 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 6f5e2a4c-828c-450d-805b-9c03c7a904bd 61 fields · synced 24 Oct 2026