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Assay Kit for Electrolytes Analysers (Ion-selective Electrode Method)
EUDAMEDClass B (EU MDR)
Ref /Model ISE A、ISE B、ISE CAL08
Identity
- Device Name
- Assay Kit for Electrolytes Analysers (Ion-selective Electrode Method) EUDAMED
- Model / Reference
- ISE A、ISE B、ISE CAL08 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740739566 EUDAMED
- Basic UDI-DI
- 69357407ICAS000039B9 EUDAMED
- EMDN Code
- W01010403 MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R. EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
Assay Kit for Electrolytes Analysers (Ion-selective Electrode Method) by URIT Medical Electronic Co., Ltd. — Class B — IVDR — listed in EUDAMED
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 | 69357407ICAS000039B9 | Class B | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1b489272-d371-44c7-879e-82c8f0a3fdf2 61 fields · synced Oct 7, 2026