This company holds 37 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, Australia, Hong Kong — 8 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.
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20263011752 | 微波消融仪 | Class III |
| CN | 国械注准20263011747 | 一次性使用微波消融针 | Class III |
| CN | 国械注准20253090551 | 陡脉冲治疗设备 | Class III |
| CN | 国械注准20253011804 | 一次性使用射频消融电极针 | Class III |
| EU | 06937278617620 | — | Class IIa |
| EU | 06937278617613 | — | Class IIa |
| EU | 06937278617606 | — | Class IIa |
| EU | 06937278617590 | — | Class IIa |
| UK | 35886 | Disposable Biopsy Needle | Class IIa |
| UK | 58836 | Irreversible Electroporation Ablation Generator | Class IIb |
| UK | 58836 | Irreversible Electroporation Probe | Class IIb |
| US | K244018 | Disposable Biopsy Needle | 2025-07-22 |
| US | K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | 2025-01-24 |
| US | K242322 | Bone Marrow Biopsy Needle | 2025-01-24 |
| BR | 80269339016 | Cânula Automática para Biópsia | Class II |
| BR | 81573909005 | Cânula Semiautomática para Biópsia | Class II |
| BR | 81573909006 | Cânula Semiautomática para Biópsia com Cânula Coaxial | Class II |