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Carilex

by Carilex Medical, Inc United States EUDAMED

Ref S1001-3042

EMDN Z12019003

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471987369S1XXXRV Basic UDI-DIDate6 Feb 2023RegisteredStatusActive

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
Negative Pressure Wound Therapy System
Model / Reference
S1001-3042
Primary DI / UDI-DI
04719873696697
Basic UDI-DI
471987369S1XXXRV
Direct Marketing DI
04719873696697
EMDN Code
Z12019003 Wound treatment equipment
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000002145
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Carilex Medical, Inc.

See all devices from Carilex Medical, Inc. →

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 300dcfc2-349a-4bc9-8bbe-acd1a023d161 61 fields · synced 22 Oct 2026