Hotgen (Langfang) Biotech Co., Ltd.
China Last updated 8 Jun 2026
- Devices
- 23
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Wash Reagent Ref HGOTHER09
Interleukin 8 Chemiluminescence Immunoassay Kit (CLIA) Ref 60T：HGCL56
Interleukin 10 Chemiluminescence Immunoassay Kit (CLIA) Ref 60T：HGCL57
Interleukin 2 Chemiluminescence Immunoassay Kit (CLIA) Ref 60T：HGCL55
Automatic Chemiluminescence Immunoassay Analyzer Ref HGC2100
Automatic Chemiluminescence Immunoassay Analyzer Ref HGMQ60 proB
Automatic Chemiluminescence Immunoassay Analyzer Ref HGMQ60 plus
Substrate Module Ref HGOTHER03
Wash Reagent Ref HGOTHER07
Automatic Chemiluminescence Immunoassay Analyzer Ref HGMQ60 smart
Substrate Module Ref HGOTHER04
Up-converting Phosphor Immunoassay Analyzer Ref HGUPT2800
Wash Reagent Ref HGOTHER08
Substrate Module Ref HGOTHER02
Glycosylated Hemoglobin Hemolytic Agent Ref HGOTHER01
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Frequently asked questions
How many devices does Hotgen (Langfang) Biotech Co., Ltd. have in the registry?
The registry currently lists 23 devices for Hotgen (Langfang) Biotech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hotgen (Langfang) Biotech Co., Ltd.'s devices?
Among its 23 most recently registered devices, Hotgen (Langfang) Biotech Co., Ltd. has devices listed in EUDAMED (23 devices).
What risk classes do Hotgen (Langfang) Biotech Co., Ltd.'s devices fall under?
Among its 23 most recently registered devices, the classes recorded for Hotgen (Langfang) Biotech Co., Ltd.'s devices are IVDR Class A and IVD general. Each device page shows its own class and authorisation.
What are the newest devices from Hotgen (Langfang) Biotech Co., Ltd. in the registry?
The most recently registered devices listed for Hotgen (Langfang) Biotech Co., Ltd. include Intact Parathyroid Hormone Chemiluminescence Immunoassay Kit (CLIA), Aldosterone Chemiluminescence Immunoassay Kit (CLIA), Wash Reagent and Bone Gla Protein Chemiluminescence Immunoassay Kit (CLIA).
Information
- Address
- No. 70, Guandong Road, Guangyang District, Langfang, Hebei, China
- Website
- hotgen.com.cn
- [email protected]
- PRRC contact
- shaohua yu
- EUDAMED SRN
- CN-MF-000018899