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CM-320i Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref 3013370Model CM-320i
Identity
- Trade Name
- CM-320i Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- CM-320i EUDAMED3013370 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794520036 EUDAMED
- Basic UDI-DI
- 69257945W0201020103D0KA EUDAMED
- EMDN Code
- W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) EUDAMED
Classification
- Device Class
- Class A 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
CM-320i Chemiluminescence Immunoassay Analyzer 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 | 69257945W0201020103D0KA | 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 44b848c9-24e4-4ad9-a4b4-cc7c2140e965 61 fields · synced Jul 29, 2026