FDA 一类产品备案多少钱

更新时间：2024-11-14 07:10:00

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详细介绍

- 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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FDA 一类产品备案多 少 钱