This company holds 7 NMPA certificates in China and has registrations in European Union, United States, Brazil, Singapore, South Korea, Australia, Israel, Russia — 8 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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| CN | 国械注许20262080019 | 网式雾化器 | Class II · 2026-08-17 |
| CN | 国械注许20162080440 | 吐气端细菌过滤器加热器Expiratory Bacteria Filter Heater | Class II · 2025-02-25 |
| CN | 国械注许20172080307 | 一次性使用喷雾瓶组“愷得”噴霧瓶組 | Class II · 2024-09-24 |
| CN | 国械注许20232080003 | 正压通气面罩愷得連續性正壓面罩組及其附件 | Class II · 2023-02-14 |
| EU | 04719894386737 | Reusable Airway Connector | Class IIa |
| EU | 04719894386768 | Airway Connector | Class IIa |
| EU | 04719894390642 | Bacteria Filter (Non-Sterile) | Class IIa |
| EU | 04719894386133 | Airway Connector | Class IIa |
| BR | 80113019004 | FILTRO DE BACTÉRIA | Class II |
| BR | 80113019005 | RESSUSCITADOR PULMONAR MANUAL REUSAVEL | Class II |
| BR | 80113019006 | RESSUSCITADOR PULMONAR MANUAL DESCARTÁVEL | Class II |