This company holds 35 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥298, 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20253062309 | 高压造影注射器系统套件 | Class III |
| CN | 国械注准20243061231 | 一次性使用高压造影注射器及附件 | Class III |
| CN | 国械注准20243060429 | 高压造影注射器管路系统 | Class III |
| CN | 国械注准20233140276 | 一次性使用连通板 | Class III |
| EU | 06938327906450 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | Class IIa |
| EU | 06938327906443 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | Class IIa |
| EU | 06938327906436 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | Class IIa |
| EU | 06938327909918 | Sterile High-pressure Angiographic Syringes for Single-use | Class IIa |
| UK | 16545 | Sterile High-pressure Angiographic Syringes for Single-use | Class IIa |
| UK | 47259 | Sterile High-pressure Angiographic Syringes for Multi-use | Class IIa |
| UK | 47259 | Sterile High-pressure Angiographic Syringes for Multi-use | Class IIa |
| US | K241109 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | 2024-08-22 |
| US | K211564 | Sterile High-pressure Angiographic Syringes for Single-use | 2021-10-19 |
| US | K192657 | Sterile High-pressure Angiographic Syringes for Single-use | 2020-08-07 |
| BR | 80136719021 | Tubo conector para transferência de líquidos em sistema fechado, com 2 | Class II |
| BR | 80136719017 | Seringa Optivantage | Class II |
| BR | 80136710215 | TUBO CONECTOR | Class II |