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Electrolyte Reagent
EUDAMEDClass IVD General (EU MDR)
Ref 42035001Model DS-I（No.3）
Identity
- Trade Name
- Electrolyte Reagent EUDAMED
- Device Name
- Electrolyte Reagent EUDAMED
- Model / Reference
- DS-I（No.3） EUDAMED42035001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334803119 EUDAMED
- Basic UDI-DI
- B-06950334803119 EUDAMED
- EMDN Code
- W01010403 MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R. EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania 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 Reagent by Genrui Biotech Inc. — 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-06950334803119 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 48852c14-71e0-423b-8f7d-ffaf4e1bcf4d 61 fields · synced Jul 9, 2026