山东 FDA 一 类产品注册 备案 费 用 是多少?
更新时间：2024-11-14 07:10:00
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详细介绍
FDA 企业注册费、一 类产品备案费，二类产品510K注册费分别是多少?
FDA 注册、备案全部费用包括：FDA行政收费（官费）、产品检验费、注册备案代办费。以下是FDA行政收费（官费）列表。
2025 企业注册费9280$， 无优惠减免，II类产品 510（K）技术审评费 务小规模6084$, 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。
以下是FDA 分类目录 CFR 868 麻醉科中一类医疗器械目录，
| 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 |
| ANESTHESIOLOGY | PCM | Portable liquid oxygen unit stand | I | 510(K) exempted |
| ANESTHESIOLOGY | PHIS | Oral Airway Assist | I | 510(K) exempted |
| ANESTHESIOLOGY | PXE | Pressure monitoring (air/gas) kit | I | 510(K) exempted |
| ANESTHESIOLOGY | OYI | Non-bronchoscopic bronchoalveolar lavage catheter | I | 510(K) exempted |
| ANESTHESIOLOGY | BXW | CALIBRATOR, VOLUME, GAS | I | 510(K) exempted |
| ANESTHESIOLOGY | BZW | STETHOSCOPE, ESOPHAGEAL | I | 510(K) exempted |
| ANESTHESIOLOGY | BZS | STETHOSCOPE HEAD | I | 510(K) exempted |
| ANESTHESIOLOGY | JFE | VALVE, SWITCHING (PLOSS) | I | 510(K) exempted |
| ANESTHESIOLOGY | BXA | ANALYZER, GAS, WATER VAPOR, GASEOUS-PHASE | I | 510(K) exempted |
| ANESTHESIOLOGY | CCN | FLOWMETER, NONBACK-PRESSURE COMPENSATED,BOURDON GAUGE | I | 510(K) exempted |
| ANESTHESIOLOGY | BYM | TUBE, THORPE, UNCOMPENSATED | I | 510(K) exempted |
| ANESTHESIOLOGY | CAX | Flowmeter, tube, thorpe, back-pressure compensated | I | 510(K) exempted |
| ANESTHESIOLOGY | BXY | FLOWMETER, CALIBRATION, GAS | I | 510(K) exempted |
| ANESTHESIOLOGY | JAY | SUPPORT, BREATHING TUBE | I | 510(K) exempted |
| ANESTHESIOLOGY | CBL | ABSORBENT, CARBON-DIOXIDE | I | 510(K) exempted |
| ANESTHESIOLOGY | BSF | ABSORBER, CARBON-DIOXIDE | I | 510(K) exempted |
| ANESTHESIOLOGY | BTC | BAG, RESERVOIR | I | 510(K) exempted |
| ANESTHESIOLOGY | CAT | CANNULA, NASAL, OXYGEN | I | 510(K) exempted |
| ANESTHESIOLOGY | BZB | CATHETER, NASAL, OXYGEN | I | 510(K) exempted |
| ANESTHESIOLOGY | BYN | CHAIR, POSTURE, FOR CARDIAC AND PULMONARYTREATMENT | I | 510(K) exempted |
| ANESTHESIOLOGY | BYD | CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) | I | 510(K) exempted |
| ANESTHESIOLOGY | BTB | HOOK, ETHER | I | 510(K) exempted |
| ANESTHESIOLOGY | BTP | DROPPER, ETHER | I | 510(K) exempted |
| ANESTHESIOLOGY | BYO | BOTTLE, BLOW | I | 510(K) exempted |
| ANESTHESIOLOGY | CAI | Circuit, breathing (w connector, adaptor, y piece) | I | 510(K) exempted |
| ANESTHESIOLOGY | KFZ | HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME.USE) | I | 510(K) exempted |
| ANESTHESIOLOGY | CAL | LARYNGOSCOPE, NON-RIGID | I | 510(K) exempted |
| ANESTHESIOLOGY | CCW | LARYNGOSCOPE, RIGID | I | 510(K) exempted |
| ANESTHESIOLOGY | BSJ | MASK, GAS, ANESTHETIC | I | 510(K) exempted |
| ANESTHESIOLOGY | BTK | STRAP HEAD. GAS MASK | I | 510(K) exempted |
| ANESTHESIOLOGY | KGB | MASK, OXYGEN, NON-REBREATHING | I | 510(K) exempted |
| ANESTHESIOLOGY | CBH | DEVICE, FIXATION, TRACHEAL TUBE | I | 510(K) exempted |
| ANESTHESIOLOGY | BWB | FORCEPS, TUBE INTRODUCTION | I | 510(K) exempted |
| ANESTHESIOLOGY | BSR | STYLET, TRACHEAL TUBE | I | 510(K) exempted |
| ANESTHESIOLOGY | EPE | BRUSH, CLEANING, TRACHEAL TUBE | I | 510(K) exempted |
| ANESTHESIOLOGY | BZA | CONNECTOR, AIRWAY (EXTENSION) | I | 510(K) exempted |
| ANESTHESIOLOGY | BRW | Protector, dental | I | 510(K) exempted |
| ANESTHESIOLOGY | BYX | TUBING, PRESSURE AND ACCESSORIES | I | 510(K) exempted |
| ANESTHESIOLOGY | CBG | SPREADER, CUFF | I | 510(K) exempted |
| ANESTHESIOLOGY | BZ0 | SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) | I | 510(K) exempted |
| ANESTHESIOLOGY | BYH | DRAIN, TEE (WATER TRAP) | I | 510(K) exempted |
| ANESTHESIOLOGY | BRYE | Cabinet, table and tray, anesthesia | I | 510(K) exempted |
| ANESTHESIOLOGY | BZN | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDINGEQUIPMENT) | I | 510(K) exempted |
| ANESTHESIOLOGY | BX | CLIP, NOSE | I | 510(K) exempted |
| ANESTHESIOLOGY | BXK | GAS, CALIBRATION (SPECIFIED CONCENTRATION) | I | 510(K) exempted |
| ANESTHESIOLOGY | BRX | STOOL, ANESTHESIA | I | 510(K) exempted |
| ANESTHESIOLOGY | BSY | CATHETERS, SUCTION, TRACHEOBRONCHIAL | I | 510(K) exempted |
| ANESTHESIOLOGY | CCX | SUPPORT, PATIENT POSITION | I | 510(K) exempted |
| ANESTHESIOLOGY | CAM | YOKE ASSEMBLY, MEDICAL GAS | I | 510(K) exempted |
| ANESTHESIOLOGY | BXL | ALGESIMETER, MANUAL | I | 510(K) exempted |
| ANESTHESIOLOGY | CBT | Arterial blood sampling kit | I | 510(K) exempted |
| ANESTHESIOLOGY | KGK | GAS, COLLECTING VESSEL | I | 510(K) exempted |
| ANESTHESIOLOGY | NQV | Catheter, suction, tracheobronchial, reprocessed | I | 510(K) exempted |
| ANESTHESIOLOGY | ECX | Cylinder, compressed gas, and valve | I | 510(K) exempted |
| ANESTHESIOLOGY | OFO | Airway suction kit | I | 510(K) exempted |
| ANESTHESIOLOGY | OFR | Tracheobronchial suction catheter kit | I | 510(K) exempted |
| ANESTHESIOLOGY | OFS | Tracheal suction set | I | 510(K) exempted |
| ANESTHESIOLOGY | OFZ | Blood specimen collection kit (excludes HlV testing) | I | 510(K) exempted |
| ANESTHESIOLOGY | OGH | Laryngoscope kit | I | 510(K) exempted |
| ANESTHESIOLOGY | OGI | Nasal endotracheal tube holder kit | I | 510(K) exempted |
| ANESTHESIOLOGY | QWA | Cardiovascular Delivery Catheter System Positioning andStabilization Device | I | 510(K) exempted |
| ANESTHESIOLOGY | MOP | Rotator, prosthetic heart valve | I | 510(K) exempted |
| ANESTHESIOLOGY | LDE | STETHOSCOPE, MANUAL | I | 510(K) exempted |
| ANESTHESIOLOGY | OFA | Cardiovascular surgical instruments tray | I | 510(K) exempted |
| ANESTHESIOLOGY | DQC | Phonocardiograph | I | 510(K) exempted |
| ANESTHESIOLOGY | DRJ | SYSTEM, SIGNAL ISOLATION | I | 510(K) exempted |
| ANESTHESIOLOGY | DRI | MONITOR, LINE ISOLATION | I | 510(K) exempted |
| ANESTHESIOLOGY | DSM | ALARM, LEAKAGE CURRENT, PORTABLE | I | 510(K) exempted |
| ANESTHESIOLOGY | DSF | RECORDER, PAPER CHART | I | 510(K) exempted |
| ANESTHESIOLOGY | MWS | Stabilizer, heart | I | 510(K) exempted |
| ANESTHESIOLOGY | LXN | PROBE, TEST, HEART-VALVE | I | 510(K) exempted |
| ANESTHESIOLOGY | NQG | Stabilizer, heart, non-compression, reprocessed | I | 510(K) exempted |
| ANESTHESIOLOGY | DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR | I | 510(K) exempted |
| ANESTHESIOLOGY | DSW | BAG, POLYMERIC MESH, PACEMAKER | I | 510(K) exempted |
| ANESTHESIOLOGY | KRF | CHARGER, PACEMAKER | I | 510(K) exempted |
| ANESTHESIOLOGY | DTG | MAGNET, TEST, PACEMAKER | I | 510(K) exempted |
| ANESTHESIOLOGY | DTF | TOOLS, PACEMAKER SERVICE | I | 510(K) exempted |
| ANESTHESIOLOGY | DTJ | HOLDER, HEART-VALVE, PROSTHESIS | I | 510(K) exempted |
| ANESTHESIOLOGY | DTI | SIZER, HEART-VALVE, PROSTHESIS | I | 510(K) exempted |
| ANESTHESIOLOGY | KRI | ACCESSORY EOUIPMENT. CARDIOPULMONARY BYPASS | I | 510(K) exempted |
| ANESTHESIOLOGY | PMK | CPR Aid device without feedback | I | 510(K) exempted |
| ANESTHESIOLOGY | PSM | Refractometer for donor testing | I | 510(K) exempted |
| ANESTHESIOLOGY | PTC | Uric acid test system for at home prescription use | I | 510(K) exempted |
了解更多FDA 一类医疗器械产品及一类产品备案事项，可联系深圳市思博达医疗科技有限公司 www.bccgd.com 或 彭先生 136微信2238同号0915
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