JASDI CHEMICALS CO., LTD.
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JASDI CHEMICALS CO., LTD.

FDA Medical Device Registration

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FDA Medical Device Registration

FDA Medical Device Registration

Product Parameters

Product Name FDA Medical Device Registration
Item No. Medical devices registration
Supply Type Sell
Category Industrial Supplies Hardware > Industrial Parts > UL FDA

Detailed Product Description

The FDA defines a medical device as:
  • "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
If your product is labeled or used in a manner that meets this definition it will be regulated as a medical device and is subject to the FDA’s laws and regulations before, during, and after it is offered for sale or use in the United States.

Keywords: UL FDA  FDA Medical Device Registration   

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Company Name JASDI CHEMICALS CO., LTD.
Country/Region Taiwan
City Taichung City
Address No. 8, Ln. 819, Sec. 3, Zhongqing Rd., Daya Dist.,
Zip / Postal Code 42878
Telephone +886-4-25685848
Fax +886-4-25685857
Contact Person
Catagories: Coating