Identity
- Trade Name
- CA CLEAN II EUDAMED
- Device Name
- CA CLEAN II EUDAMED
- Model / Reference
- 96406136 EUDAMEDCJ038739 EUDAMED974-0581-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987562516848 EUDAMED14987562509550 EUDAMED04987562516858 EUDAMED14987562516879 EUDAMED
- Basic UDI-DI
- 4987562CACLEANIIG6 EUDAMED
- EMDN Code
- W0103020999 AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER 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
Yes
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
Ca Clean 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 | 4987562CACLEANIIG6 | 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 (4)
- EUDAMED 2cd67d1e-ac0a-4e39-86ba-09ab24ee33c4 61 fields · synced Aug 3, 2026
- EUDAMED 77c99d89-495e-433b-85dd-3e50b5673445 61 fields · synced May 16, 2026
- EUDAMED 79a1bbb3-4fef-43f3-9fa2-de2e6bdad4c3 61 fields · synced May 18, 2026
- EUDAMED 8ad3500c-66ab-4567-bb91-f8ca23d0858b 61 fields · synced May 19, 2026