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ParaProTM XLT

by SLMP LLC d.b.a. StatLab Medical Products United States EUDAMED

Ref PPXLT

EMDN W05030599

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08600084104PP001F2 Basic UDI-DIDate24 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
ParaProTM SEM
Model / Reference
PPXLT
Primary DI / UDI-DI
00860008410436
Basic UDI-DI
08600084104PP001F2
EMDN Code
W05030599 Devices for patology tests - other
Device Class
Class A
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
US-MF-000029059
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from SLMP LLC d.b.a. StatLab Medical Products

See all devices from SLMP LLC d.b.a. StatLab Medical Products →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 7f40a3d7-1359-4966-bdda-827edf1d9508 61 fields · synced 22 Oct 2026