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intelligent Esophageal Pressure System

by PulmoTech BV EUDAMED

Active European Union

Ref C01-125-12-01Model intelligent Esophageal Pressure System

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8720648560IEPSA9 Basic UDI-DIDate15 Aug 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
intelligent Esophageal Pressure System
Model / Reference
intelligent Esophageal Pressure System, C01-125-12-01
Primary DI / UDI-DI
87206485600028
Basic UDI-DI
8720648560IEPSA9
Direct Marketing DI
87206485600028
EMDN Code
Z12039099 Various instruments to support and monitor vital signs – other
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000013242

Other devices from PulmoTech BV

Properties

Show properties
  • Sterile
  • Administering Medicine
  • Measuring Function
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Incorporates Medicinal Product: No