Identity
- Trade Name
- CS-5100 EUDAMEDAutomated Blood Coagulation Analyzer CS-5100 FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory FDA UDI
- Device Name
- Automated Blood Coagulation Analyzer EUDAMEDA fully automated blood coagulation analyzer intended for in vitro diagnostic use. FDA UDI
- Model / Reference
- BY990757 EUDAMEDCU624138 FDA UDI
- Description
- A fully automated blood coagulation analyzer intended for in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- BY990757 FDA UDI
- Primary DI / UDI-DI
- 04987562518654 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987562CS-5100P8 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
Cs-5100 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 | 4987562CS-5100P8 | 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 037192e7-bf9a-46a2-9b06-f508698c74bc 61 fields · synced May 30, 2026
- FDA UDI eb52c904-2dde-40f0-ab2e-f34c525805d5 35 fields · synced May 30, 2026