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Eightcheck-3wp
EUDAMEDClass IVD General (EU MDR)
Ref AT566446Ref AH650456Ref AK636886Ref AT965319
Identity
- Device Name
- EIGHTCHECK-3WP EUDAMED
- Model / Reference
- AT566446 EUDAMEDAH650456 EUDAMEDAK636886 EUDAMEDAT965319 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-AT5664464D EUDAMEDD-AH650456UR EUDAMEDD-AK636886XV EUDAMEDD-AT9653195J EUDAMED
- Basic UDI-DI
- B-AT5664464D EUDAMEDB-AH650456UR EUDAMEDB-AK636886XV EUDAMEDB-AT9653195J EUDAMED
- EMDN Code
- W0103010599 HAEMATOLOGY CONTROLS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
Eightcheck-3wp by Sysmex Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-AT5664464D | Class IVD General | 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 784df348-645b-45eb-9056-d6b6d37b6a16 61 fields · synced Jul 25, 2026
- EUDAMED d5fb8aaa-16f2-403d-adf8-451c2c51f24b 61 fields · synced May 18, 2026
- EUDAMED c254fce1-50d3-4b04-99e5-7b61d293af59 61 fields · synced May 18, 2026
- EUDAMED f1385ca9-2932-49a4-b063-6983f1fa03d3 61 fields · synced May 19, 2026