Cell-Free DNA BCT CE

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Device Name

Cell-Free DNA BCT CE

Model / Reference

230244

Primary DI / UDI-DI

60844509002255

Basic UDI-DI

08445090CFBCTCEBX

Direct Marketing DI

60844509002255

EMDN Code

W050101010201 Blood collection, tubes with additives or serum separator

Device Class

Class A

EU market of registration

Germany

EUDAMED SRN

US-MF-000013009

Authorised representative

MediMark Europe Sarl. FR-AR-000000182

• Cell-Free DNA BCT CE

  Class A

  CE/IVDR

• Xn Check Bf

  Class II

  FDA 510(k) K141957 Active Cleared 5 Dec 2014

• Cell-Free DNA BCT

  Class II

  FDA 510(k) K231776 Active Cleared 26 Jul 2024

• Xn Check

  Class II

  FDA 510(k) K160590 Active Cleared 22 Dec 2016

• Xn Cal

  Class II

  FDA 510(k) K160585 Active Cleared 22 Dec 2016

• Xn-L Check

  Class II

  FDA 510(k) K160586 Active Cleared 22 Dec 2016

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