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Fully Automatic Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref RL-C4000
Identity
- Device Name
- Fully Automatic Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- RL-C4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792050914 EUDAMED
- Basic UDI-DI
- 697179205CF7 EUDAMED
- Direct Marketing DI
- 06971792050914 EUDAMED
- EMDN Code
- W0201020299 LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER 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
Fully Automatic Chemiluminescence Immunoassay Analyzer by Hangzhou Realy Tech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697179205CF7 | Class A | Unknown |
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Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED be082eb0-1b6a-400c-b05f-9a7788c719ed 61 fields · synced Jun 18, 2026