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Electrolytes Analyzer
EUDAMEDClass A (EU MDR)
Ref K-Lite8BModel K-Lite8AModel K-Lite8A、K-Lite8B、K-Lite8D、K-Lite8E、K-Lite8F、K-Lite8G、K-Lite8H、K-Lite8
Identity
- Device Name
- Electrolytes Analyzer EUDAMEDElectrolyte Analyzer EUDAMED
- Model / Reference
- K-Lite8A EUDAMEDK-Lite8B EUDAMEDK-Lite8A、K-Lite8B、K-Lite8D、K-Lite8E、K-Lite8F、K-Lite8G、K-Lite8H、K-Lite8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947929500614 EUDAMED
- Basic UDI-DI
- 69479295K-Lite5H EUDAMED
- EMDN Code
- W0201040102 BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters) EUDAMEDW0201040101 BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMEDEUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Electrolytes Analyzer by Meizhou Cornley Hi-Tech 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 | 69479295K-Lite5H | Class A | Active |
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Manufacturer
- Manufacturer
- Meizhou Cornley Hi-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000025014
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 9386deaf-08b8-43de-885c-3bb07ada017a 61 fields · synced Jun 19, 2026
- EUDAMED 0017ef26-1542-4fcb-96e6-36d4467d25a3 61 fields · synced Jun 19, 2026