Identity
- Trade Name
- Integrated System EUDAMED
- Device Name
- Integrated System EUDAMED
- Model / Reference
- CSM-8000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202256622 EUDAMED
- Basic UDI-DI
- B-06942202256622 EUDAMED
- EMDN Code
- W0201030103 MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput > 2000 test/h) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Integrated System by Dirui Industrial Co., Ltd — 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-06942202256622 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 977eb238-d79c-4d59-bff6-55f0c8ad1ce2 61 fields · synced Jul 23, 2026