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Cs-300b
EUDAMEDClass A (EU MDR)
Ref 3009594Model DR-7000D CS-T180 CS-T240 CS-T240Plus CS-300B CS-400 CS-480
Identity
- Trade Name
- CS-300B EUDAMED
- Device Name
- Chemistry Analyzer EUDAMED
- Model / Reference
- DR-7000D CS-T180 CS-T240 CS-T240Plus CS-300B CS-400 CS-480 EUDAMED3009594 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794576088 EUDAMED
- Basic UDI-DI
- 69257945W0201010101D0JF EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Cs-300b by Dirui Industrial Co., Ltd — 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 | 69257945W0201010101D0JF | Class A | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f944936d-088e-44d0-86dc-6d56941936cd 61 fields · synced Jun 18, 2026