FDA 一类产品备案多 少 钱
- 申报备案产品Device Class、Product Code、Regulation Number、Proprietary Name、Medical Specialty的确定
- FDA 注册备案技术文件准备
- 美国邓白 氏代码申请及获取
- FDA Establishment Registration and List账号申请与获取
- FDA PIN 号码申请及获取
- FDA 工厂注册账号付费，PCN码获取
- 美国代理人甄选和确认
- FDA 公司注册和产品列名
- 美国UDI及GUDID申请
- ……
附：FDA CFR 868 麻醉用品医疗器械中的 一类医疗器械目录
| ANESTHESIOLOGY | BYG | MASK, OXYGEN | I | 510(K) exempted |
| ANESTHESIOLOGY | KHA | MASK, SCAVENGING | I | 510(K) exempted |
| ANESTHESIOLOGY | BYF | MASK, OXYGEN, LOW CONCENTRATION, VENTURI | I | 510(K) exempted |
| ANESTHESIOLOGY | BYP | MOUTHPIECE, BREATHING | I | 510(K) exempted |
| ANESTHESIOLOYG | CCQ | NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) | I | 510(K) exempted |
| ANESTHESIOLOGY | BYW | DEVICE, REBREATHING | I | 510(K) exempted |
| ANESTHESIOLOGY | BYL | TENT, OXYGEN | I | 510(K) exempted |
| ANESTHESIOLOGY | FOG | HOOD, OXYGEN, INFANT | I | 510(K) exempted |
| ANESTHESIOLOGY | BXH | GAUGE, GAS PRESSURE, CYLINDER/PIPELINE | I | 510(K) exempted |
| ANESTHESIOLGOY | BXX | CALIBRATOR, PRESSURE, GAS | I | 510(K) exempted |
| ANESTHESIOLOGY | CAN | Regulator, pressure, gas cylinder | I | 510(K) exempted |
| ANESTHESIOLOGY | BYR | TRANSDUCER, GAS PRESSURE, DIFFERENTIAL | I | 510(K) exempted |
| ANESTHESIOLOGY | BXP | TRANSDUCER, GAS FLOW | I | 510(K) exempted |
| ANESTHESIOLOGY | BXO | TRANSDUCER, GAS PRESSURE | I | 510(K) exempted |
| ANESTHESIOLOGY | BTQ | AIRWAY, NASOPHARYNGEAL | I | 510(K) exempted |
| ANESTHESIOLOGY | CAE | AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | I | 510(K) exempted |
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