Anorectal Manometry Catheter Kit
Disposable catheter kit for anorectal manometry measures anal sphincter pressure and rectal sensitivity during functional assessment. Classified under HTS 9018.19.40.00 for functional exploratory examination apparatus and accessories. Includes pressure sensors and balloon components.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If used solely for therapeutic drug delivery rather than diagnostic pressure measurement
Syringes, needles, and catheters for therapeutic use classified separately from diagnostic apparatus.
If basic plastic tubing without integrated pressure sensors
Plain plastic articles without electro-diagnostic function fall under Chapter 39 plastics.
If imported as bulk components for assembly
Unfinished parts and accessories classified separately from complete functional kits.
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Import Tips & Compliance
• Ensure ISO 13485 certification for sterile single-use catheters
• Provide pressure calibration certificates with each shipment
• Label clearly as 'single-use only' to meet FDA enforcement discretion policies
Related Products under HTS 9018.19.40.00
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Rectal Barostat Catheter
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