Identity
- Device Name
- SB Cuvette II EUDAMEDSB Cuvette EUDAMED
- Model / Reference
- CM500820 EUDAMED06410419 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987562516964 EUDAMED04987562418664 EUDAMED04987562516957 EUDAMED
- Basic UDI-DI
- 4987562SBCuvetteIIM4 EUDAMED4987562SBCuvetteB5 EUDAMED
- EMDN Code
- W0503010203 SAMPLES ANALYSES, PLASTIC CUVETTES 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
No
EUDAMED
New Device
No
EUDAMED
SB Cuvette II 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 | 4987562SBCuvetteIIM4 | Class A | Active |
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Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (3)
- EUDAMED 44be0584-0995-4283-8c06-ae4a808f1d42 61 fields · synced Jul 26, 2026
- EUDAMED 004beda0-33b2-4f11-af58-3624e9558040 61 fields · synced May 17, 2026
- EUDAMED 3da33c1b-9ec7-46d7-8a63-a66894e35bd0 61 fields · synced May 19, 2026