Identity
- Trade Name
- CN-6000 EUDAMEDAutomated Blood Coagulation Analyzer CN-6000 FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory FDA UDI
- Device Name
- Automated Blood Coagulation Analyzer CN-6000 EUDAMEDThe CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods. The performance of this device has not been established in neonate and pediatric patient populations. FDA UDI
- Model / Reference
- CV339763 EUDAMEDAX801645 FDA UDI
- Description
- The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods. The performance of this device has not been established in neonate and pediatric patient populations. FDA UDI
Identifiers
- Catalog Number
- CV339763 FDA UDI
- Primary DI / UDI-DI
- 04987562518630 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987562CN-6000M9 EUDAMED
- FDA Product Code
- JPA FDA UDI
- EMDN Code
- W0202020102 AUTOMATED COAGULOMETERS EUDAMED
- GMDN Term
- Coagulation analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Market of Registration
- Germany 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
No
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
No
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
Yes
FDA UDI
Cn-6000 by Sysmex Corporation — 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 | 4987562CN-6000M9 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (2)
- EUDAMED 3a61f205-1e58-41fc-8386-80eda7f5f292 61 fields · synced Jul 8, 2026
- FDA UDI 9cda2a67-cd33-4e2d-bf4c-b6dfb8056c71 35 fields · synced May 30, 2026