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Edwards EVOQUE Loading System

by Edwards Lifesciences LLC United States EUDAMED

Ref 9850LSB

EMDN P07038002

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0690103D004EVL000WV Basic UDI-DIDate7 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
EVOQUE Loading System
Model / Reference
9850LSB
Primary DI / UDI-DI
00690103219548
Basic UDI-DI
0690103D004EVL000WV
EMDN Code
P07038002 Cardiac valve transcatheter implant accessories
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
  • 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 (1)

  • EUDAMED 00690103219548|0690103D004EVL000WV 61 fields · synced 24 Oct 2026