发布时间：2006-10-13
FDA经常扣押医疗器械产品信息
近期，我们注意到相当数量的出口美国的医疗器械的中国制造商或贸易公司经常有产品被美国海关扣留，很多厂商对FDA注册了解甚少甚至不知道所出口的产品按照美国法律需要进行FDA强制性注册，这不仅影响了正常的交货期，还可能增加不必要的仓储费用甚至产品被美国海关退回或扣押；
我们提示下列产品的厂商/贸易商近早联络IRC China, 以便我们为您近早申请FDA注册，为顺利通关提供基本条件：
Wooden massager
Vibrators
Body weight scale
Back massager
ADHESIVE BANDAGE
ELASTIC BANDAGES
Medical oxygen generator
Autoclave/Steam sterilizer
Surgical Mask
Weight scale, sunglasses
MAGNIFYING SPECTACLE
SPECTACLE FRAME, Laser point
Sterilization Pouches/Pack/Wrap/Bag For Medical
Powered wheelchair
Mechanical wheelchair
ADHESIVE WOUND DRESSING/SURGICAL TAPE
TRANSPARENT DRESSING
TRANSPARENT SEMI-PERMEABLE DRESSING
SURGICAL FILM
Blood Irradiation Indicators
Electrosurgical Control Pencil
Limb holder, protector
Patient examination glove
Rollator with brakes
Unscented menstrual pad
Face Mask/Surgical Mask
First Aid Kit
Medical X-ray Processor
Infrared Ear Thermometer
Digital Clinical thermometer
Sanitary napkin
MERCURY THERMOMETER
Medical Stainless Steel Instrument
Bathroom Series
Rollator, sampler
Ultrasonic file, Eye and Brain Massager
Plastic Clogs
Medical degrease gauze
Medical scissors
STETHOSCOPE
Surgical apparel
Surgical Towel
Gauze
Swabs
Lap Sponges
Microscope lamps
Colposcope
Disposable Preparation Razor Kit
Catheterization Assistance Kit
Condom
Urine Bag
Homecare beds
Fingertip Oximeter
MRI Coil
HCG Urine Strip
Surgicel Absorbable Hemostat
Natural Biological Protein Suture
Compressor Nebulizer
Contact lens case
Stretcher
Vaginal Dilator for Single Use
Computer controlled shampooing & bathing trolley
Electronic Auto-controlled Tower Trolley
Medical lift stretcher trolley
MEDICAL ELECTRONIC AUTO-CONTROLLED AIR MATTRESS
Blood Line Set
Ultrasonic Scaler
Scalpel
Cutter
Suture needle
Suture
IV Bag
Dental instruments
Ultrasonic Diagnostic Device for Ophthalmology
Pisoton syringe& Hypodermic single lumen needle
Surgical Gown
Surgical Mask
Surgical Drape
Sphygmomanometer
等等。
大部分一类产品可直接通过授权被FDA列名的FDA注册事务美国代理人US Agent进行制造商/设施注册Establishment Registration Number，FDA拥有权人注册Owner Number和产品/器械列名Device Listing;2类产品需要通过先申请FDA510(K)号码才能进行公司注册和产品列名。
International Regulatory Consultants, LLC (IRC)是被FDA官方列名的提供美国代理人服务(US Agent)的美国代理人,与其他以食品和药品为主要业务的代理人不同，IRC仅活跃于医疗器械FDA注册和美国代理人服务领域，所以我们更求提供专业和务实的服务；为国内厂商顺利开拓美国市场提供坚实的基础；
欲了解进一步信息，请访问我们网站的其他介绍或与我们的中国服务代表联络，我们会热忱为您提供解答。感谢您的支持和信任，期待您的问讯！
IRC编译整理
www.FDAChina.com
