← Back to catalogue

SAS-1 Cholesterol Profile Kit

EUDAMED

Class IVD General (EU MDR)

Ref 200602

by Helena Biosciences Europe

Identity

Trade Name: SAS-1 Cholesterol Profile Kit EUDAMED
Device Name: SAS-1 Cholesterol Profile Kit EUDAMED
Model / Reference: 200602 EUDAMED

Identifiers

Primary DI / UDI-DI: 05056013009245 EUDAMED
Basic UDI-DI: B-05056013009245 EUDAMED
EMDN Code: W01010205 CHOLESTEROL EUDAMED

Classification

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

SAS-1 Cholesterol Profile Kit by Helena Biosciences Europe — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

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: Helena Biosciences Europe
EUDAMED SRN: GB-MF-000028365
Authorised Representative: Advena Limited MT-AR-000000234

Sources (1)

EUDAMED 3283e8b6-9fe7-49eb-b79a-a58ce3e789b9 61 fields · synced Jun 19, 2026