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SALSA MLPA Probemix P189 CDKL5-FOXG1

by MRC Holland B.V. EUDAMED

Active European Union

Ref P189-100R

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number872021148P1896K Basic UDI-DIDate16 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
SALSA MLPA Probemix P189 CDKL5/ARX/FOXG1
Model / Reference
P189-100R
Primary DI / UDI-DI
08720211482663
Basic UDI-DI
872021148P1896K
EMDN Code
W0106010199 Monogenetic disorders tests - other
Device Class
Class C
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000000437

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Properties

Show properties
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No