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FDA Medical Device Registration Form

1. Establishment Details
 
 
   
   
   
2. Establishment Contact
 
   
   
   
3. Type of Operation
Manufacturer  Contract Manufacturer   Contract Sterilizer   Specification Developer   Initial Importer   Foreign Exporter   Relabeler   Other (Explain)  
4. US Importer / Distributor
   
   
5.1 Device Listing Information - 1
 
 
   
5.2 Device Listing Information - 2
 
 
   
5.3 Device Listing Information - 3
 
 
   
5.4 Device Listing Information - 4
 
 
   
5.5 Device Listing Information - 5
 
 
   
6. US FDA Medical Device Registration Form Submitter Information
Submitter Name   Job Title   Submitter E-mail