This company holds 49 NMPA certificates in China and has registrations in United States, United Kingdom, Brazil, Canada, Australia, Hong Kong, Russia — 7 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20233400364 | 新型冠状病毒（ 2019-nCoV）抗原检测试剂盒（乳胶法） | Class III |
| CN | 浙械注准20252401928 | 25-羟基维生素D测定试剂盒（荧光免疫层析法） | Class II |
| CN | 浙械注准20252401462 | 便隐血检测试剂盒（胶体金法） | Class II |
| CN | 浙械注准20252401250 | 尿酸试纸（电化学法） | Class II |
| UK | 41252 | 25-Hydroxyvitamin D3 (25-OH-D3) Control Solution (FIA) | IVD general |
| UK | 54063 | Alpha Fetoprotein Control Solution (FIA) | IVD general |
| UK | 58411 | Anti-Mullerian Hormone Control Solution (FIA) | IVD general |
| US | K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | 2026-05-22 |
| US | K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | 2025-09-12 |
| US | K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader | 2024-10-04 |
| BR | 81692610289 | Famila Proxima ALIVE Ácido Úrico | Class II |
| BR | 81869089004 | LANCETADOR | Class II |
| BR | 81869089003 | VivaChek twist lancets | Class II |