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Xn-L Check
EUDAMEDClass IVD General (EU MDR)
Ref CC211992Ref AE908164Ref BS660546
Identity
- Device Name
- XN-L CHECK EUDAMED
- Model / Reference
- CC211992 EUDAMEDAE908164 EUDAMEDBS660546 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CC211992RE EUDAMEDD-AE908164TW EUDAMEDD-BS6605463P EUDAMED
- Basic UDI-DI
- B-CC211992RE EUDAMEDB-AE908164TW EUDAMEDB-BS6605463P 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
Xn-L Check 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-CC211992RE | 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 e31cdced-ffa7-41b4-a6e2-bc99b80acb7a 61 fields · synced Jul 31, 2026
- EUDAMED 9a9c3b52-d9c2-4b0a-b56b-9406750a5516 61 fields · synced May 17, 2026
- EUDAMED c42d8787-10f9-40c7-95a1-81376f591c2e 61 fields · synced May 18, 2026