Interferon-γ test (Chemiluminescence Immunoassay)

by Beijing Hotgen Biotech Co., Ltd. EUDAMED

Active European Union

Ref HGCL53Model Please see the IFU

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697029753458M5 Basic UDI-DI	Date19 Aug 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference: Please see the IFU, HGCL53

Primary DI / UDI-DI: 06936700408935
Basic UDI-DI: 697029753458M5
EMDN Code: W01030601 INTERFERONS (α, β, ɣ…)

Device Class: Class B
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000015566
Authorised representative: MedNet EC-REP GmbH DE-AR-000000002

Other devices from Beijing Hotgen Biotech Co., Ltd.

Vascular Endothelial Growth Factor test (Chemiluminescence Immunoassay)

Class B
Ferritin test (Up-converting Phosphor Technology)

Class B
One Step Syphilis Anti-TP Test (Colloidal Gold)

Class C
Total Immunoglobulin E test (Chemiluminescence Immunoassay)

Class B
Total Immunoglobulin E test (Up-converting Phosphor Technology)

Class B
Dengue IgM/IgG Rapid test (Colloidal Gold)

Class B

See all devices from Beijing Hotgen Biotech Co., Ltd. →

Properties

Animal Tissues
Reagent
Professional Testing

Other properties (8)

Sterile: No
Human Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No