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

EUDAMED

Class IVD General (EU MDR)

Ref 95H160TRef 95H40TSC

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: 95H160T EUDAMED
95H40TSC EUDAMED

Identifiers

Primary DI / UDI-DI: D-95H160TBR EUDAMED
D-95H40TSCVW EUDAMED
Basic UDI-DI: B-95H160TBR EUDAMED
B-95H40TSCVW 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

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

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: Yhlo Biotech (nanjing) Co., Ltd.
EUDAMED SRN: CN-MF-000050474
Authorised Representative: Medunion S.L. ES-AR-000019366

Sources (2)

EUDAMED c0daf269-27a4-4743-8f11-9013ededd3e7 61 fields · synced Jul 28, 2026
EUDAMED a5db1993-0e66-4179-a840-320e999299ae 61 fields · synced May 18, 2026