Identity
- Trade Name
- Printer Kit WW EUDAMED
- Device Name
- Quantra Hemostasis Analyzer EUDAMED
- Model / Reference
- KT-0015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850003761114 EUDAMED
- Basic UDI-DI
- 08500037610001CX EUDAMED
- EMDN Code
- W0202029080 VARIOUS HEMOSTASIS INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMED
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
Printer Kit WW by Hemosonics LLC — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 08500037610001CX | Class A | Active |
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Manufacturer
- Manufacturer
- Hemosonics LLC
- EUDAMED SRN
- US-MF-000034476
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED b015a0d0-d8b1-47c1-a7d6-21c54ec593e5 61 fields · synced Jul 16, 2026