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Blood Gas & Electrolyte Analyzer
EUDAMEDClass A (EU MDR)
Ref Gaslite80BModel Gaslite80A、Gaslite80B、Gaslite80、Gaslite80AQ、Gaslite80BQ、Gaslite80Q、Gaslite80E
Identity
- Device Name
- Blood Gas & Electrolyte Analyzer EUDAMED
- Model / Reference
- Gaslite80A、Gaslite80B、Gaslite80、Gaslite80AQ、Gaslite80BQ、Gaslite80Q、Gaslite80E EUDAMEDGaslite80B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947929500447 EUDAMED
- Basic UDI-DI
- 69479295Gaslite80Z2 EUDAMED
- EMDN Code
- W0201040102 BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters) EUDAMED
Classification
- Device Class
- Class A 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
Blood Gas & Electrolyte 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 | 69479295Gaslite80Z2 | 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 (1)
- EUDAMED 7f40833b-8e74-4d09-82ba-8d07f9dc503c 61 fields · synced Jun 18, 2026