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Immunoglobulin G (IgG) Assay Kit (Immunoturbidimetric Method)

EUDAMED

Class IVD General (EU MDR)

Ref 120H60TSC

by Yhlo Biotech (nanjing) Co., Ltd.

Identity

Trade Name
Immunoglobulin G (IgG) Assay Kit (Immunoturbidimetric Method) EUDAMED
Device Name
Immunoglobulin G (IgG) Assay Kit (Immunoturbidimetric Method) EUDAMED
Model / Reference
120H60TSC EUDAMED

Identifiers

Primary DI / UDI-DI
D-120H60TSCZU EUDAMED
Basic UDI-DI
B-120H60TSCZU EUDAMED
EMDN Code
W0102010105 IMMUNOGLOBULIN G 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: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

Immunoglobulin G (IgG) Assay Kit (Immunoturbidimetric Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED

Similar devices

Also classified as Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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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 (1)

  • EUDAMED f69c2da7-6307-4662-8dbb-d9a00a3b6803 61 fields · synced Oct 7, 2026