Manufacturer

Hotgen

ChinaLegal entities : Beijing Hotgen Biotech Co., Ltd., Hotgen (Langfang) Biotech Co., Ltd.

Markets : Germany · United States

Approvals : EU – class A, B, C · United States (FDA) – · class I, II

EU representative : MedNet EC-REP GmbH (Germany)

service@hotgen.com.cn

9 categories, 20 models including 20 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Various sample processing instruments - other	W02069099	Automatic Chemiluminescence Immunoassay Analyzer C2100 Automatic Chemiluminescence Immunoassay Analyzer C800 Automatic Chemiluminescence Immunoassay Analyzer MQ60 plus Automatic Chemiluminescence Immunoassay Analyzer MQ60 proB Automatic Chemiluminescence Immunoassay Analyzer MQ60 smart 2 others Automatic Chemiluminescence Immunoassay Analyzer Please see IFU Up-converting Phosphor Immunoassay Analyzer UPT2800	A IVDR	EUDAMED record Report an error
Other interleukins (except for il-6)	W01030606	Interleukin 10 Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79 Interleukin 1β Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79 Interleukin 2 Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79 Interleukin 8 Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79	– 98/79	EUDAMED record Report an error
Interferons (α, β, ɣ…)	W01030601	Interferon Gamma Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79 Interferon-γ test (Chemiluminescence Immunoassay) Please see the IFU	B IVDR, 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	Interleukin-6 test (Up-converting Phosphor Technology ) Please see the IFU98/79 Interleukin-6 test (Chemiluminescence Immunoassay) Please see the IFU	B IVDR, 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer test (Chemiluminescence Immunoassay) Please see the IFU	C IVDR	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgM/IgG Rapid test (Colloidal Gold) Please see the IFU2 refs	B IVDR	EUDAMED record Report an error
Haemoglobin subtypes hba2, hbc, hbf, hbs, etc.(excl. hba1)	W0103010202	Glycosylated Hemoglobin test (Chemiluminescence Immunoassay) Please see the IFU	C IVDR	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	One Step Syphilis Anti-TP Test (Colloidal Gold) Please see the IFU2 refs	C IVDR	EUDAMED record Report an error
Tumour necrosis factors (tnfα,tnfβ, ...)	W01030603	Tumor Necrosis Factor Alpha Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79	– 98/79	EUDAMED record Report an error

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