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Reagent for Electrolyte Analyzer (Direct Method)
EUDAMEDClass IVD General (EU MDR)
Ref BF0128PModel 500mL(RA:1×430mL+RB:1×70mL)
Identity
- Trade Name
- Reagent for Electrolyte Analyzer (Direct Method) EUDAMED
- Device Name
- Reagent for Electrolyte Analyzer (Direct Method) EUDAMED
- Model / Reference
- 500mL(RA:1×430mL+RB:1×70mL) EUDAMEDBF0128P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595776744 EUDAMED
- Basic UDI-DI
- B-06936595776744 EUDAMED
- EMDN Code
- W01010399 ELECTROLYTES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Reagent for Electrolyte Analyzer (Direct Method) by Medicalsystem Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06936595776744 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED df62ae83-528c-441d-8ae4-148f04ca193d 61 fields · synced Jun 18, 2026