Electrolyte Analyzer
by Nanjing Poweam Medical Co., Ltd China EUDAMED
Ref EL-2400Model EL-1100, EL-1100PLUS, EL-1200, EL-2200, EL-2300，EL-2400
EMDN W0201040101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697722645BTEA01LS | Date11 Apr 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- EL-1100, EL-1100PLUS, EL-1200, EL-2200, EL-2300，EL-2400, EL-2400
- Primary DI / UDI-DI
- 06977226455881
- Basic UDI-DI
- 697722645BTEA01LS
- EMDN Code
- W0201040101 BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
- Device Class
- Class A
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000040207
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Nanjing Poweam Medical Co., Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
Sources (1)
- EUDAMED 06977226455881|697722645BTEA01LS