← Back to catalogue

Total Cholesterol (CHO) Assay Kit (CHOD-PAP Method)

EUDAMED

Class IVD General (EU MDR)

Ref R: 2×60 mL

by Shenzhen AmTech Bioengineering Ltd., Inc.

Identity

Device Name: Total Cholesterol (CHO) Assay Kit (CHOD-PAP Method) EUDAMED
Model / Reference: R: 2×60 mL EUDAMED

Identifiers

Primary DI / UDI-DI: 06937287300049 EUDAMED
Basic UDI-DI: B-06937287300049 EUDAMED
EMDN Code: W01010205 CHOLESTEROL EUDAMED

Classification

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

Total Cholesterol (CHO) Assay Kit (CHOD-PAP Method) by Shenzhen AmTech Bioengineering Ltd., Inc. — Class IVD General — IVDD — listed in EUDAMED

Similar devices

Also classified as Total cholesterol lipid IVD, reagent.

FORA — FORA CARE INC. · Class I
OS-CHOL — PZ CORMAY Spółka Akcyjna · IVD General
Cholesterol (CHOL) Assay Kit (Oxidase Method) — YHLO BIOTECH (NANJING) CO., LTD. · IVD General
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
Liquick Cor-CHOL 30 — PZ CORMAY Spółka Akcyjna · IVD General
Total Cholesterol (TC) — Maccura Biotechnology Co., Ltd. · IVD General

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
EUDAMED SRN: CN-MF-000043067
Authorised Representative: SUNGO Europe B.V. NL-AR-000000247

Sources (1)

EUDAMED 36186524-2a5c-4fb8-88dc-ff826d3f69f4 61 fields · synced Jul 30, 2026