This company holds 77 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 13 overseas markets. EU UDI-DI records ≥160, 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20243082088 | 呼吸机 | Class III |
| CN | 苏械注准20262160886 | 眼部雾化器 | Class II |
| CN | 苏械注准20262071109 | 腕部动态血压记录仪 | Class II |
| CN | 苏械注准20262070537 | 指夹式脉搏血氧仪 | Class II |
| EU | 06933257951754 | Electronic blood pressure monitor | Class IIa |
| EU | 06933257951730 | Electronic blood pressure monitor | Class IIa |
| EU | 06933257951723 | Electronic blood pressure monitor | Class IIa |
| EU | 06933257951686 | Electronic blood pressure monitor | Class IIa |
| UK | 10226 | Mesh Nebulizer | Class IIa |
| UK | 10226 | Mesh Nebulizer | Class IIa |
| UK | 45617 | Electronic Blood Pressure Monitor | Class IIa |
| US | K261571 | Manual Wheelchair (H008, PCK7) | 2026-08-06 |
| US | K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | 2026-03-05 |
| US | K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | 2026-02-23 |
| BR | 80102519304 | Nebulizador de malha | Class II |
| BR | 80889460042 | Cadeira de Rodas Prime | Class I |
| BR | 82165950001 | Cadeira de Rodas Manual, YUWELL, modelos K1, K2, K3, K4. | Class I |
| SA | ME0000005037SFDAA00014 | WHEELCHAIR | — |
| SA | ME0000005037SFDAA00006 | Air mattress | — |