FDA 注册收 费 是多少
FDA 企业注册费、I 类产品备案费，二类产品510K注册费分别是多少
2025 企业注册费9280$， 无优惠减免，II类产品 510（K）技术审评费 小规模6084$, 相比2024分别递增21.26% 和11.8%！
2024 企业 注册费7653$， 无优惠减免， 510（K）技术审评费 小规模5440$, 相比2023分别递增17.87% 和9.52%！
2023 企业注册费6493$， 无优惠减免，510（K）技术审评费 小规模4967$，相比2022 分别递增14.47% 和55.90%！
2022 企业注册费5672$， 无优惠减免，510（K）技术审评费 小规模3186$
划重点，FDA一类产品备案不收费，二类产品510K及企业注册费如上，每年略有不同!
详情及需要申请美国FDA医疗器械产品注册和备案，可联系深圳市思博达彭先生或登录公司网站www.bccgd.com。
| 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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