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Reference electrode
EUDAMEDClass IVD General (EU MDR)
Ref DJ8001PModel 29*15*26mm
Identity
- Trade Name
- Reference electrode EUDAMED
- Device Name
- Reference electrode EUDAMED
- Model / Reference
- 29*15*26mm EUDAMEDDJ8001P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595774382 EUDAMED
- Basic UDI-DI
- B-06936595774382 EUDAMED
- EMDN Code
- W0101070301 REFERENCE ELECTRODES 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
Reference electrode by Medicalsystem Biotechnology 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-06936595774382 | 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 168f54e1-b72d-4bd8-a794-3d300e8a8adb 61 fields · synced Jul 23, 2026