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Electrolyte Analyzer
EUDAMEDClass A (EU MDR)
Ref CBS-30Model CBS-300, CBS-301, CBS-400, CBS-401, CBS-500, CBS-501, CBS-30, CBS-40, CBS-50, CBS-3, CBS-4, CBS-5, KS-401, KS-402
Identity
- Device Name
- Electrolyte Analyzer EUDAMED
- Model / Reference
- CBS-300, CBS-301, CBS-400, CBS-401, CBS-500, CBS-501, CBS-30, CBS-40, CBS-50, CBS-3, CBS-4, CBS-5, KS-401, KS-402 EUDAMEDCBS-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972337851379 EUDAMED
- Basic UDI-DI
- 697233785EA006CC EUDAMED
- EMDN Code
- W0201040201 ION SELECTIVE ELECTROLYTE ANALYSERS 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 B&E Bio-Technology 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 | 697233785EA006CC | Class A | Active |
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Manufacturer
- Manufacturer
- B&E Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023256
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 52b66c67-57bc-4c62-9ab2-ec7ba7c2966c 61 fields · synced Jun 18, 2026