Identity
- Trade Name
- Hemochron™ Signature Elite EUDAMEDHemochron Whole Blood Microcoagulation System FDA UDI
- Generic Name
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
- Device Name
- Hemochron™ Signature Elite EUDAMEDHemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument FDA UDI
- Model / Reference
- ELITE EUDAMEDFDA UDI
- Description
- Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument FDA UDI
Identifiers
- Catalog Number
- ELITE FDA UDI
- Primary DI / UDI-DI
- 10711234510018 EUDAMEDFDA UDI
- Basic UDI-DI
- 0711234510011LU EUDAMED
- FDA Product Code
- JPA FDA UDI
- EMDN Code
- W0202020101 SEMI-AUTOMATED COAGULOMETERS EUDAMED
- GMDN Term
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Hemochron™ Signature Elite by Accriva Diagnostics, Inc. — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193041 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 0711234510011LU | 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 (3)
- EUDAMED 8b6b3dc5-2c1e-43d4-95ec-c075b61a1816 61 fields · synced Jun 19, 2026
- FDA UDI 5df49d88-5450-4950-bdfc-992ded074653 35 fields · synced May 30, 2026
- FDA 510(k) K193041 1 fields · synced May 18, 2026