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Hemochron™ Whole Blood Microcoagulation System
EUDAMEDClass A (EU MDR)
Ref ELITEINT
Identity
- Trade Name
- Hemochron™ Whole Blood Microcoagulation System EUDAMED
- Device Name
- Hemochron™ Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument (International) EUDAMED
- Model / Reference
- ELITEINT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10711234510032 EUDAMED
- Basic UDI-DI
- 0711234510035MA EUDAMED
- EMDN Code
- W0202020101 SEMI-AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Hemochron™ Whole Blood Microcoagulation System by Accriva Diagnostics, Inc. — 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 | 0711234510035MA | Class A | Active |
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Manufacturer
- Manufacturer
- Accriva Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000009902
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 4b5ee742-38e4-4c5c-9746-0eac5a7ab263 61 fields · synced Jul 22, 2026