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CM-180 Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref 3015506Model CM-180
Identity
- Trade Name
- CM-180 Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- CM-180 EUDAMED3015506 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794515025 EUDAMED
- Basic UDI-DI
- 69257945W0201020102D0K5 EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Romania 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-180 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 | 69257945W0201020102D0K5 | 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 bfe43fb0-41aa-4761-80f4-67e0cfe0e27e 61 fields · synced Jul 9, 2026