Establishment Registration & Device Listing

Establishment Name	Registration Number	Current Registration Yr
COLOPLAST HUNGARY KFT HUNGARY	3003814961	2024
collector, ostomy - 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		Manufacturer
bag, urine collection, leg, for external use, sterile - Conveen Contour; Conveen Security+		Manufacturer
bag, drainage, with adhesive, ostomy - COLOPLAST FISTULA AND WOUND MANAGAMENT SYSTEM; Coloplast Fistula Bed Drainage Bag; Coloplast Flexible Lid		Manufacturer
bag, urine collection, leg, for external use, non-sterile - Coloplast Bedside Drainage Bag; Conveen Active; Conveen Contour; Conveen Leg Bag Strap; Conveen Security+; Conveen Standard; Conveen Urine Bag Hanger		Manufacturer
irrigator, ostomy - Assura Irrigation Pressplate; Assura Irrigation Set; Assura Ostomy Bag; Coloplast Irrigation Colotip; SenSura Mio Hospital Irrigation Set; SenSura Mio Irrigation Sleeve; Sensura Mio Irrigation Sleeves		Manufacturer
catheter, retention type, balloon - X-flow		Repackager/Relabeler
catheter, retention type, balloon - Folysil		Repackager/Relabeler
lavage, jet - ELEFANT (TM) Suction-Irrigation Device		Manufacturer
catheter, ureteral, gastro-urology - KT RUP		Repackager/Relabeler
catheter, ureteral, gastro-urology - Floppy Tip Hydro-Coated Ureteric Catheters; Flush Ureteric Catheters; Ureteric Catheters		Repackager/Relabeler
dilator, catheter, ureteral - In-Ka® Ureteral Balloon Dilatation Catheters		Repackager/Relabeler
stent, ureteral - Vortek Single Loop Ureteral Stent		Repackager/Relabeler
stent, ureteral - Kolibri Direct Puncture Sets; Kolibri Percutaneous Nephrostomy Catheters; Kolibri Percutaneous Nephrostomy Kits		Repackager/Relabeler
catheter, nephrostomy - Kolibri Direct Puncture Sets; Kolibri Percutaneous Nephrostomy Catheters; Kolibri Percutaneous Nephrostomy Kits		Repackager/Relabeler
endoscopic injection needle, gastroenterology-urology - BoNee Needle		Repackager/Relabeler
catheter, continuous irrigation - COLOPLAST DRAIN PORT		Manufacturer; Repackager/Relabeler
dilator, catheter, ureteral - Ureteral Dilators and Percutaneous Nephrostomy Dilators		Repackager/Relabeler

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