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TruWave

by Edwards Lifesciences LLC United States EUDAMED

Ref PX15S162

EMDN Z12030299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0690103D001CBL000ML Basic UDI-DIDate29 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Reusable cables
Model / Reference
PX15S162
Primary DI / UDI-DI
00690103220780
Basic UDI-DI
0690103D001CBL000ML
Direct Marketing DI
00690103220780
EMDN Code
Z12030299 Vital signs monitoring instruments - other
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000007139
Authorised representative
Edwards Lifesciences GmbH DE-AR-000006184

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 00690103220780|0690103D001CBL000ML 61 fields · synced 25 Oct 2026