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SPOTCHEM II Total Cholesterol

EUDAMED

Class IVD General (EU MDR)

Ref 77162

by ARKRAY Factory, Inc.

Identity

Trade Name: SPOTCHEM II Total Cholesterol EUDAMED
Device Name: SPOTCHEM II Total Cholesterol EUDAMED
Model / Reference: 77162 EUDAMED

Identifiers

Primary DI / UDI-DI: D-77162J7 EUDAMED
Basic UDI-DI: B-77162J7 EUDAMED
EMDN Code: W01010205 CHOLESTEROL EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Finland 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

Category: Total cholesterol lipid IVD, reagent

SPOTCHEM II Total Cholesterol by ARKRAY Factory, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Total cholesterol lipid IVD, reagent.

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OS-CHOL — PZ CORMAY Spółka Akcyjna · IVD General
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HeartsCare C1 Total Cholesterol Test Strip (10pcs/box) — Hearts Bio, Inc. · Class I
Teco Diagnostics Cholesterol TC-Matrix-480 — TECO DIAGNOSTICS · Class I
DIRUI — DIRUI INDUSTRIAL CO., LTD · IVD General
Colesterolo Totale — GIESSE DIAGNOSTICS SRL · IVD General
Liquick Cor-CHOL 30 — PZ CORMAY Spółka Akcyjna · IVD General

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: ARKRAY Factory, Inc.
EUDAMED SRN: JP-MF-000003008
Authorised Representative: ARKRAY Europe, B.V. NL-AR-000002056

Sources (1)

EUDAMED 815c9b7d-5e6b-41fc-b320-2fa1ce67a5b6 61 fields · synced Jul 9, 2026