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Printer Kit WW

by Hemosonics LLC

Ref KT-0015

Printer Kit WW (KT-0015) is a Class A device made by Hemosonics LLC, registered in EUDAMED on 16 Mar 2026 (Basic UDI-DI 08500037610001CX), active as of 22 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08500037610001CX Basic UDI-DI 00850003761114UDI-DIDate16 Mar 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Quantra Hemostasis Analyzer
Model / reference
KT-0015
Primary DI / UDI-DI
00850003761114
Basic UDI-DI
08500037610001CX
EMDN code
W0202029080 Various hemostasis instruments - hardware accessories
Device class
Class A
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000034476
Authorised representative
QbD RepS BV BE-AR-000000040

Similar devices in this category

Other devices filed under VARIOUS HEMOSTASIS INSTRUMENTS.

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Properties

  • Near-patient testing
  • Professional testing
  • IVD instrument
Other properties (10, all answered No)