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Electrolyte Analyzer Supporting Reagent(Ion Selective Electrode Method and Pres…
EUDAMEDClass IVD General (EU MDR)
Ref "REF: U0680910M U0680910N USCE00000079 U0670910D1M U0670910D2M U0670910C1M U0670910C2M"
Identity
- Device Name
- Electrolyte Analyzer Supporting Reagent(Ion Selective Electrode Method and Pressure Method) EUDAMED
- Model / Reference
- "REF: U0680910M U0680910N USCE00000079 U0670910D1M U0670910D2M U0670910C1M U0670910C2M" EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6-139FT EUDAMED
- Basic UDI-DI
- B-6-139FT EUDAMED
- EMDN Code
- W01010403 MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R. EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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 Analyzer Supporting Reagent(Ion Selective Electrode Method and Pres… by URIT Medical Electronic Co., Ltd. — Class IVD General — IVDD — listed in…
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-6-139FT | Class IVD General | 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 cd3581d5-67e3-4016-93ac-212dd9e0399c 61 fields · synced Jul 29, 2026