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Electrolyte Control
EUDAMEDClass IVD General (EU MDR)
Ref QC-5 low：2.0mL×5、normal：2.0mL×5、high：2.0mL×5Model QC-5 , QCP-5, QC-TCO2
Identity
- Device Name
- Electrolyte Control EUDAMED
- Model / Reference
- QC-5 , QCP-5, QC-TCO2 EUDAMEDQC-5 low：2.0mL×5、normal：2.0mL×5、high：2.0mL×5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972337850150 EUDAMED
- Basic UDI-DI
- B-06972337850150 EUDAMED
- EMDN Code
- W0101050204 ELECTROLYTE CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Electrolyte Control by B&E Bio-Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06972337850150 | Class IVD General | 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 50ce2367-9818-45e3-8a0a-c2c3c33df193 61 fields · synced Jul 17, 2026