FDA 药品与器械查询
实时对接美国 FDA 官方开放数据（openFDA），可查询美国上市药品 NDC 目录、医疗器械管理类别与 21 CFR 法规号、以及已获许可的 510(k) 清单，用于出海美国的准入判断、注册路径选择与同类竞品调研。支持中文关键词自动转英文检索。
数据源：美国 FDA 官方开放数据平台 openFDA，实时查询美国上市药品 NDC 目录、器械分类与 510(k) 许可，用于出海美国的准入与合规自查。
支持中文关键词自动转英文检索；此为美国监管口径，与中国 NMPA 批准情况相互独立。
查询器械在 FDA 的管理类别（I/II/III 类）、产品代码与 21 CFR 法规号，是判断注册路径（豁免 / 510(k) / PMA）的第一步。
已将中文关键词转为英文「insulin」检索 FDA 数据库。
共找到 18 条与「insulin」匹配的结果
当前展示 18 条FDA 器械分类记录； 海关数据库提供全球买卖明细与竞争对手出货记录咨询完整数据 ›
| 器械名称 | 管理类别 | 产品代码 | 法规号（21 CFR） | 所属科室 | 定义 / 用途 |
|---|---|---|---|---|---|
| Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System | III 类 | SFI | — | Unknown | The device is intended to measure glucose in interstitial fluid. It is intended to provide those measurements as inputs to appropriately qualified digitally connected devices, including automated insulin dosing systems, as determined by FDA. |
| Pump, Infusion, Insulin | II 类 | LZG | 21 CFR 880.5725 | General Hospital | |
| Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals | II 类 | QCC | 21 CFR 862.1358 | Clinical Chemistry | An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors. |
| Automated Insulin Dosing , Threshold Suspend | III 类 | OZO | — | Unknown | An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels. |
| Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | III 类 | OYC | — | Unknown | The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor. |
| Interoperable Automated Glycemic Controller, Insulin Suspend | II 类 | QJS | 21 CFR 862.1356 | Clinical Chemistry | An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control. |
| Pump, Infusion, Insulin Bolus | II 类 | OPP | 21 CFR 880.5725 | General Hospital | The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus. |
| Insulin Autoantibody Kit | II 类 | OCN | 21 CFR 866.5660 | Immunology | The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy. |
| Automated Insulin Dosing Device System, Bihormonal Control | III 类 | OZQ | — | Unknown | A bihormonal automated insulin dosing system that achieves a target glucose level by automatically adjusting two glucose modulating therapies from an infusion pump. Hormone adjustments are based upon specified thresholds of measured glucose levels. |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | II 类 | QLG | 21 CFR 862.1355 | Clinical Chemistry | An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems. |
| Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | I 类 | OAM | 21 CFR 862.1550 | Clinical Chemistry | The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women. |
| Continuous Glucose Monitor Informed Insulin Dose Calculator | II 类 | QRX | 21 CFR 862.1358 | Clinical Chemistry | A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information. |
| Insulin Vial Protector/Holder | I 类 | OJL | 21 CFR 890.5050 | Physical Medicine | The device is intended to protect an insulin vial or vials |
| Automated Insulin Dosing Device System, Single Hormonal Control | III 类 | OZP | — | Unknown | An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels. |
| Insulin Pump Secondary Display | II 类 | PKU | 21 CFR 862.1350 | Clinical Chemistry | The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring. |
| Radioimmunoassay, Immunoreactive Insulin | I 类 | CFP | 21 CFR 862.1405 | Clinical Chemistry | |
| Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions | III 类 | LMY | — | Unknown | |
| Alternate Controller Enabled Insulin Infusion Pump | II 类 | QFG | 21 CFR 880.5730 | Clinical Chemistry | An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery. |
数据随 FDA 官方库更新，仅供参考，不构成医学或法律建议；正式注册与报关请以 FDA 官方文件及最新法规为准。