← Back to catalogue

Apolipoprotein A1 (APO-A1) Assay (immunoturbidimetric Method )

EUDAMED

Class IVD General (EU MDR)

Ref 95H40T

by Yhlo Biotech (nanjing) Co., Ltd.

Identity

Trade Name: Apolipoprotein A1 (APO-A1) Assay (immunoturbidimetric Method ) EUDAMED
Device Name: Apolipoprotein A1 (APO-A1) Assay (immunoturbidimetric Method ) EUDAMED
Model / Reference: 95H40T EUDAMED

Identifiers

Primary DI / UDI-DI: D-95H40TXW EUDAMED
Basic UDI-DI: B-95H40TXW EUDAMED
EMDN Code: W0102010401 APOLIPOPROTEIN A I EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Spain 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: Apolipoprotein A-I (Apo A1) IVD, reagent

Apolipoprotein A1 (APO-A1) Assay (immunoturbidimetric Method ) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Similar devices

Also classified as Apolipoprotein A-I (Apo A1) IVD, reagent.

APOLIPOPROTEÍNA A1 — QUIMICA CLINICA APLICADA S.A. · IVD General
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Nephstar Apo A1 Kit — Goldsite Diagnostics Inc. · IVD General
APO A1 — Medicon Hellas SA · IVD General
Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
Apolipoprotein A1 — Diagam S.A. · IVD General
Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
Apolipoprotein A1 Reagent Kit — HANGZHOU AICHEK MEDICAL TECHNOLOGY 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: Yhlo Biotech (nanjing) Co., Ltd.
EUDAMED SRN: CN-MF-000050474
Authorised Representative: Medunion S.L. ES-AR-000019366

Sources (1)

EUDAMED 84a17388-f81c-41a0-b5b6-e0cd152251da 61 fields · synced Jun 18, 2026