Identity
- Trade Name
- Cleaning Cartridge EUDAMEDQuantra QPlus System FDA UDI
- Generic Name
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
- Device Name
- Quantra Hemostasis Analyzer EUDAMEDQuantra Cleaning Cartridge FDA UDI
- Model / Reference
- KT-0012 EUDAMEDFDA UDI
- Description
- Quantra Cleaning Cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850003761043 EUDAMEDFDA UDI
- Basic UDI-DI
- 08500037610001CX EUDAMED
- 510(k) Number
- DEN180017 FDA UDI
- FDA Product Code
- QFR FDA UDI
- EMDN Code
- W0202029085 VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5430 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cleaning Cartridge by Hemosonics LLC — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 08500037610001CX | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Hemosonics LLC
- EUDAMED SRN
- US-MF-000034476
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED a914f6d6-53fc-4405-a98f-29dc8c32b4f8 61 fields · synced Jul 9, 2026
- FDA UDI bac07a52-1b4e-45d4-9a95-b787faafe5ae 34 fields · synced May 30, 2026