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Please see the Device Registration and Listing website for additional information. however, these manufacturers are required to register their establishment.

If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. Check your banks SWIFT code and get all details you need for. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. Find the BIC / SWIFT code for FIN-ECO BANCA ICQ S.P.A. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile. For this reason, Business Identifier Codes (BICs) are often called SWIFT addresses or codes.Division of Molecular Genetics and Pathology SWIFT Standards, a division of The Society for Worldwide Interbank Financial Telecommunication (SWIFT), handles the registration of these codes. Where an 8-digit code is given, it may be assumed that it refers to the primary office.