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Electrolyte Analyzer
EUDAMEDClass A (EU MDR)
Ref EL-2200Model EL-1100, EL-1100PLUS, EL-1200, EL-2200, EL-2300Ref EL-1100PLUS
Identity
- Trade Name
- Electrolyte Analyzer EUDAMED
- Device Name
- Electrolyte Analyzer EUDAMED
- Model / Reference
- EL-1100, EL-1100PLUS, EL-1200, EL-2200, EL-2300 EUDAMEDEL-2200 EUDAMEDEL-1100PLUS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226450336 EUDAMED06977226450312 EUDAMED
- Basic UDI-DI
- 697722645BTEA01LS EUDAMED
- EMDN Code
- W0201040101 BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Electrolyte Analyzer by Nanjing Poweam Medical 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 | 697722645BTEA01LS | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Poweam Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000040207
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED af75b953-9518-44d2-8277-f521cf7c6e96 61 fields · synced Oct 6, 2026
- EUDAMED c0a37b09-8c3d-407a-b27d-f9454844f127 61 fields · synced May 18, 2026