Establishment Registration & Device Listing

Establishment Name	Registration Number	Current Registration Yr
COLOPLAST A/S DENMARK	9610694	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		Specification Developer
bag, urine collection, leg, for external use, sterile - Conveen Contour; Conveen Security+		Specification Developer
dressing, wound, occlusive - Band-Aid; Biatain Adhesive; Biatain Non-Adhesive; Biatain Non-Adhesive Foam Dressing; Biatain Silicone; Biatain Silicone Fit; Biatain Silicone Lite; Biatain Silicone Non-Border; Biatain Soft-Hold; Biatain Super; Brava Protective Sheets; Comfeel Plus Contour; Comfeel Plus Transparent; Neutrogena Acne Blemish Patch; Neutrogena Dots Sensitive		Specification Developer
dressing, wound, hydrophilic - Triad Hydrophilic Wound Dressing		Specification Developer
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		Specification Developer
bag, drainage, with adhesive, ostomy - COLOPLAST FISTULA AND WOUND MANAGAMENT SYSTEM; Coloplast Fistula Bed Drainage Bag; Coloplast Flexible Lid		Specification Developer
catheter, continuous irrigation - COLOPLAST DRAIN PORT		Specification Developer
dressing, wound, drug - Biatain Ag Adhesive; Biatain Ag Non-Adhesive		Specification Developer
bandage, liquid, skin protectant - Atrac-Tain; Barrier Cream; Brava Barrier Cream; Brava Lubricating Deodorant; Brava Skin Barrier Spray; Brava Skin Barrier Wipe; Brava Skin Cleanser; Coloplast Prep; Comfeel Barrier Cream; Comfeel Cleanser; Derma-Gard Wipe; Isorins; Ostomy Skin Barrier Cream; SeaClens; Shield Skin		Specification Developer
solvent, adhesive tape - Brava Adhesive Remover Spray; Brava Adhesive Remover Wipe		Specification Developer
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		Specification Developer
device, incontinence, urosheath type, non-sterile - CONVEEN OPTIMA; CONVEEN SECURITY +; FREEDOM BRAND; GIZMO; Penilex; Self-Cath Extension Tube; ULTRA SECURE; ULTRA SECURE MALE EXTERNAL CATHETER; URO-SAN		Specification Developer
dressing, wound, hydrogel without drug and/or biologic - Purilon		Specification Developer
ostomy care kit - Brava Baby Adhesive Remover		Specification Developer
catheter, urethral - SpeediCath Standard		Specification Developer
catheter, urethral - SpeediCath Flex Coude Pro		Specification Developer
dressing, wound, drug - Biatain Silicone AG		Specification Developer
catheter, urethral - SpeediCath Soft		Specification Developer
catheter, straight - SpeediCath Compact Male; SpeediCath Compact Male with SpeediBag		Specification Developer
catheter, straight - SpeediCath Flex Set; SpeediCath Flex Set with Accessories		Specification Developer
catheter, straight - Self-Cath; Self-Cath Plus		Specification Developer
enema kit - Peristeen Irrigation Accessory Unit; Peristeen Irrigation Rectal Catheter; Peristeen Irrigation TubePeristeen Irrigation Tube; Peristeen Plus balloon catheter; Peristeen Plus Transanal Irrigation System; Peristeen Plus tube; Peristeen System Strap; Peristeen Transanal Irrigation System; Peristeen™ Anal Irrigation System		Specification Developer
tubes, gastrointestinal (and accessories) - Peristeen Irrigation Accessory Unit; Peristeen Irrigation Rectal Catheter; Peristeen Irrigation TubePeristeen Irrigation Tube; Peristeen Plus balloon catheter; Peristeen Plus Transanal Irrigation System; Peristeen Plus tube; Peristeen System Strap; Peristeen Transanal Irrigation System; Peristeen™ Anal Irrigation System		Specification Developer
catheter, urethral - SpeediCath Compact Set male		Specification Developer
tray, catheterization, sterile urethral, with or without catheter (kit) - Self-Cath Closed System		Specification Developer
catheter, straight - Luja Coude		Specification Developer
catheter, straight - SpeediCath Compact; SpeediCath Compact Plus		Specification Developer
rod, colostomy - Coloplast Ostomy Rod		Specification Developer
catheter, urethral - SpeediCath Compact Set Female		Specification Developer
dressing, wound and burn, hydrogel w/drug and/or biologic - WounDres		Specification Developer
scissors, medical, disposable - Ostomy Scissors		Specification Developer
catheter, urethral - SpeediCath Flex Coude Pro		Specification Developer
catheter, straight - Sure Cath Set		Specification Developer
collector, urine, (and accessories) for indwelling catheter - Sure Cath Set		Specification Developer
dressing, wound, drug - Biatain Fiber Ag		Specification Developer

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