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PreNata NIPT

by MVZ Labor Krone GmbH EUDAMED

Active European Union

Ref PN-NIPT

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberPP12167PN.NIPT81 Basic UDI-DIDate22 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
PN-NIPT
Primary DI / UDI-DI
1312167PN-NIPT010
Basic UDI-DI
PP12167PN.NIPT81
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class IIa
Medical Purpose
Die Behandlungseinheit dient der Entnahme und dem Versand einer venösen Blutprobe für die nicht invasive Pränataldiagnostik.

Manufacturer details

EUDAMED SRN
DE-PR-000014665

Other devices from MVZ Labor Krone GmbH

See all devices from MVZ Labor Krone GmbH →

Properties

Show properties
Other properties (1)
  • Sterile: No