This company holds 57 NMPA certificates in China and has registrations in European Union, United States, Brazil, Taiwan, Australia, Hong Kong — 6 overseas markets.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| CN | 国械注准20263401142 | 甲型/乙型流感病毒抗原检测试剂盒（乳胶法） | Class III |
| CN | 国械注准20253401154 | 肺炎支原体IgM抗体检测试剂盒（胶体金法） | Class III |
| CN | 国械注准20243401092 | 多项毒品联合检测试剂盒（胶体金法） | Class III |
| CN | 国械注准20243400682 | 新型冠状病毒（2019-nCoV）抗原检测试剂盒（乳胶法） | Class III |
| EU | D-DGHB100QH | Gamma-Hydroxybutyric Acid (GHB) Rapid Test | IVD general |
| EU | D-IDAB421Q9 | Dengue IgG/IgM Rapid Test Cassette (WB/S/P) | IVD general |
| EU | D-IID53NBT | SARS-CoV-2 & Influenza A/B RT-PCR Test Kit | IVD general |
| EU | D-IRP53NHJ | Influenza A/B & RSV RT-PCR Test Kit | IVD general |
| US | K253318 | Clungene RSV Antigen Rapid Test | 2026-01-30 |
| US | K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup | 2025-08-27 |
| US | K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | 2024-11-08 |
| BR | 80991389003 | LANCETA PARA KIT COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) | Class II |