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Quantra Hemostasis Analyzer

by Hemosonics LLC

Ref HS-001De Novo DEN180017

Quantra Hemostasis Analyzer (HS-001) is a device classified as Class A in the EU and Class II in the US made by Hemosonics LLC, registered in EUDAMED on 16 Mar 2026 (Basic UDI-DI 08500037610001CX), cleared under FDA 510(k) K232215 on 24 Aug 2023 (1 earlier submission) and granted FDA De Novo DEN180017 on 12 Mar 2019, active as of 25 Oct 2026.

Active European Union and United States

CE IVDR 510(k) De Novo

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232215↗

+2 more

Trust

Unverified

Source EUDAMED, FDA De Novo, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number08500037610001CX Basic UDI-DI 00850003761008UDI-DIDate16 Mar 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK232215 Date24 Aug 2023IssuedStatusActive
United StatesFDA De NovoDENG De Novo De Novo granted · Direct NumberDEN180017 Date12 Mar 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08500037610001CX registered 16 Mar 2026 Active
  • FDA 510(k) K232215 decided 24 Aug 2023 Active· +1 more in the status table
  • FDA De Novo DEN180017 decided 12 Mar 2019 Active

Timeline

4 dated events

  1. Granted FDA De Novo DEN180017
  2. Cleared FDA 510(k) K230461
  3. Cleared FDA 510(k) K232215
  4. Registered EUDAMED 08500037610001CX

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA De Novo, FDA 510(k) Active
  • European Union CE/IVDR Active

Specification

EUDAMED · De Novo

Model / reference
HS-001
Primary DI / UDI-DI
00850003761008
Basic UDI-DI
08500037610001CX
De Novo Number
FDA product code
QFR
EMDN code
W0202029099 Various hemostasis instruments - other
Device class
Class A EUDAMED
Class II 510(k)
Regulation
21 CFR Part 864.5430
EU registration type
Standard device
EU market of registration
Belgium
Advisory committee
Hematology
FDA decision
DENG De Novo granted

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class A
510(k)
Class II

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

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 - OTHER.

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Properties

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