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Quantra Hemostasis Analyzer

EUDAMEDFDA 510(k)

Class A (EU MDR)

Ref HS-001510(k) DEN180017

by Hemosonics LLC

Identity

Trade Name
Quantra Hemostasis Analyzer EUDAMED
Device Name
Quantra Hemostasis Analyzer EUDAMED
Model / Reference
HS-001 EUDAMED

Identifiers

Primary DI / UDI-DI
00850003761008 EUDAMED
Basic UDI-DI
08500037610001CX EUDAMED
510(k) Number
DEN180017 FDA 510(k)
FDA Product Code
QFR FDA 510(k)
EMDN Code
W0202029099 VARIOUS HEMOSTASIS INSTRUMENTS - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.5430 FDA 510(k)
Regulation Number
864.5430 FDA 510(k)
Market of Registration
Belgium EUDAMED
Advisory Committee
Hematology FDA 510(k)
FDA Decision
DENG FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

Quantra Hemostasis Analyzer by Hemosonics LLC — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Hemosonics LLC
EUDAMED SRN
US-MF-000034476
Authorised Representative
QbD RepS BV BE-AR-000000040

Sources (2)

  • EUDAMED 194178e8-107f-45f8-b0ab-e116144cf27a 61 fields · synced Sep 17, 2026
  • FDA 510(k) DEN180017 24 fields · synced May 18, 2026