Reagent for Electrolyte Analyzer (Ion Selective Electrode Method)

EUDAMED

Class IVD General (EU MDR)

Ref D102Ref /

by Shenzhen Xilaiheng Medical Electronics Co., Ltd.

Identity

Device Name: Reagent for Electrolyte Analyzer (Ion Selective Electrode Method) EUDAMED
Electrolyte Analyzer EUDAMED
Model / Reference: D102 EUDAMED
/ EUDAMED

Identifiers

Primary DI / UDI-DI: 06975200380877 EUDAMED
06975200380020 EUDAMED
Basic UDI-DI: B-06975200380877 EUDAMED
697520038972J4 EUDAMED
Direct Marketing DI: 06975200380020 EUDAMED
EMDN Code: W01010403 MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R. EUDAMED
W0201040201 ION SELECTIVE ELECTROLYTE ANALYSERS EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Class A EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

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Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

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Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMEDEUDAMED

New Device

EUDAMED

Reagent for Electrolyte Analyzer (Ion Selective Electrode Method) by Shenzhen Xilaiheng Medical Electronics Co., Ltd. — Class IVD General — IVDR, IVDD…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	B-06975200380877	Class IVD General	Active
EUDAMED	European Union	CE/IVDD	B-06975200380877	Class IVD General	Active

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Manufacturer

Manufacturer: Shenzhen Xilaiheng Medical Electronics Co., Ltd.
EUDAMED SRN: CN-MF-000047090
Authorised Representative: CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (2)

EUDAMED 64223706-4567-45a7-a5b6-99fa59a68798 61 fields · synced Jul 11, 2026
EUDAMED 605de841-f22e-4956-8fa4-79f8b5317ddc 61 fields · synced Jul 11, 2026