Identity
- Trade Name
- CN-3000 EUDAMED
- Device Name
- Automated Blood Coagulation Analyzer EUDAMED
- Model / Reference
- CL971029 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987562499700 EUDAMED04987562518616 EUDAMED
- Basic UDI-DI
- 4987562CN-3000LL EUDAMED
- EMDN Code
- W0202020102 AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Cn-3000 by Sysmex Corporation — 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 | 4987562CN-3000LL | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (2)
- EUDAMED 003f8ce1-3ed6-4f2b-b957-275145ee3c6f 61 fields · synced Jul 27, 2026
- EUDAMED 79d08d32-f9ac-4af6-b14f-e642329207b3 61 fields · synced May 18, 2026