Identity
- Trade Name
- CA CLEAN I EUDAMED
- Device Name
- CA CLEAN I EUDAMED
- Model / Reference
- 964-0631-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987562509536 EUDAMED14987562517005 EUDAMED
- Basic UDI-DI
- 4987562CACLEANI6U EUDAMED
- EMDN Code
- W0202020185 COAGULOMETERS - CONSUMABLES EUDAMEDW0103020999 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 I 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 | 4987562CACLEANI6U | 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 (2)
- EUDAMED a4160918-e719-45fe-a847-a2a8a493ae7e 61 fields · synced Jul 15, 2026
- EUDAMED b5b05774-bdb3-4875-af17-5b3ffdeb9f61 61 fields · synced May 18, 2026