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Medical Device Manufacturing Enterprise License No.: No. 20050143 license granted by Shandong Food and Drug Administration for manufacturing medical devices Registration No.: No. 2580116 in 2008 approved
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Who needs establishment registration ampamp device?

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Any business or organization that manufactures, distributes, imports, or exports devices or products that require regulatory approval and oversight.
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Establishment registration and device listing is a requirement by the FDA for facilities that are involved in the production or distribution of medical devices.
Manufacturers, re-packagers, re-labelers, specification developers, and contract manufacturers are required to file establishment registration and device listing.
The establishment registration and device listing can be filled out electronically through the FDA Unified Registration and Listing System (FURLS).
The purpose of establishment registration and device listing is to provide the FDA with important information about medical device facilities and the devices they produce or distribute.
Information such as facility name and address, activities performed at the facility, devices manufactured or distributed, and contact information must be reported on the establishment registration and device listing.
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