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Electrolyte Reagent

EUDAMED

Class IVD General (EU MDR)

Ref 42041001Model DS-Ⅲ(NO.3)Ref 42044001Model DS-CRef 42048001Model GE-2

by Genrui Biotech Inc.

Identity

Trade Name
Electrolyte Reagent EUDAMED
Device Name
Electrolyte Reagent EUDAMED
Model / Reference
DS-Ⅲ(NO.3) EUDAMED
42041001 EUDAMED
DS-C EUDAMED
42044001 EUDAMED
GE-2 EUDAMED
42048001 EUDAMED

Identifiers

Primary DI / UDI-DI
06950334803201 EUDAMED
06950334803218 EUDAMED
06950334809524 EUDAMED
Basic UDI-DI
B-06950334803201 EUDAMED
B-06950334803218 EUDAMED
B-06950334809524 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

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Manufacturer

Manufacturer
Genrui Biotech Inc.
EUDAMED SRN
CN-MF-000017351
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (3)

  • EUDAMED feec9215-ed77-42b8-8729-798923576845 61 fields · synced Jul 21, 2026
  • EUDAMED 807c80d3-0969-4fdf-8f69-a8231e8eca99 61 fields · synced May 18, 2026
  • EUDAMED fa42d768-488f-43ae-ad5d-9233c12bb359 61 fields · synced May 18, 2026