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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Assura Kit; Assura Night bag; Assura Ostomy Pouch; Assura Urostomy bag; Assura Urostomy Pouch; Brava belt; Brava Belt for SenSura Mio; Brava Elastic Tape; Brava Elastic Tape Belt; Brava Elastic Tape Straight; Brava Lubricant Deodorant; Brava Mouldable Rings; Brava Paste; Brava Powder; Brava Protective Seal; Brava Protective Seal Convex; Brava Strip Paste; Coloplast Clamp; Coloplast Filtrodor; Coloplast Paste; Coloplast Rings; Coloplast Urostomy Night Bag; SenSura Click ostomy bag; SenSura Click Ostomy baseplate; SenSura Click urostomy bag; SenSura Click Xpro ostomy baseplate; SenSura Drainable bag with soft tap; Sensura Flex ostomy bag; Sensura Flex Ostomy baseplate; Sensura Flex urostomy bag; Sensura Flex Xpro ostomy baseplate; Sensura Magnum; SenSura Mio baby ostomy bag; SenSura Mio Baby ostomy baseplate; SenSura Mio Click High Output ostomy bag; SenSura Mio Click Ostomy bag; SenSura Mio Click ostomy baseplate; SenSura Mio Click urostomy bag; SenSura Mio Concave Ostomy bag; SenSura Mio Concave Ostomy baseplate; SenSura Mio Concave Urostomy bag; SenSura Mio Convex High Output ostomy bag; SenSura Mio Deep convex ostomy bag; SenSura Mio Deep convex ostomy baseplate; SenSura Mio Deep convex urostomy bag; Sensura Mio Flex; SenSura Mio Flex High Output ostomy bag; SenSura Mio Flex ostomy bag; SenSura Mio Flex ostomy baseplate; SenSura Mio Flex urostomy bag; SenSura Mio High Output ostomy bag; SenSura Mio Kids Flex ostomy bag; SenSura Mio Kids Flex urostomy bag; SenSura Mio Kids ostomy bag; SenSura Mio Kids ostomy baseplate; SenSura Mio Kids urostomy bag; SenSura Mio Light convex ostomy bag; SenSura Mio Light convex ostomy baseplate; SenSura Mio Light convex urostomy bag; SenSura Mio Original; SenSura Mio ostomy bag; SenSura Mio Post Op ostomy bag; SenSura Mio Soft convex ostomy bag; SenSura Mio Soft convex ostomy baseplate; SenSura Mio Soft convex urostomy bag; SenSura Mio Urostomy bag; SenSura Ostomy bag; SenSura Post Op ostomy bag; SenSura Urostomy bag; SenSura Xpro ostomy bag; SenSura Xpro Urostomy bag
Classification Name: COLLECTOR, OSTOMY
Product Code: EXB
Device Class: 1
Regulation Number: 876.5900
Medical Specialty: Gastroenterology
Registered Establishment Name: COLOPLAST HUNGARY KFT
Registered Establishment Number: 3003814961
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Manufacturer
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