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e-CHECK(XS)
EUDAMEDClass IVD General (EU MDR)
Ref CL552365Ref BP122483Ref AW798569
Identity
- Device Name
- e-CHECK(XS) EUDAMED
- Model / Reference
- CL552365 EUDAMEDBP122483 EUDAMEDAW798569 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CL552365XY EUDAMEDD-BP122483X3 EUDAMEDD-AW7985698S EUDAMED
- Basic UDI-DI
- B-CL552365XY EUDAMEDB-BP122483X3 EUDAMEDB-AW7985698S 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
e-CHECK(XS) 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-CL552365XY | 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 (3)
- EUDAMED 4cdaef3c-3c61-4c94-ba4e-b17344a1b056 61 fields · synced Aug 2, 2026
- EUDAMED b13c0328-8c95-43ea-af10-833f51adc931 61 fields · synced May 17, 2026
- EUDAMED 56677a6a-8817-45bf-8a8c-d4e75528d730 61 fields · synced May 18, 2026