Establishment Registration & Device Listing

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Establishment
Name

Registration Number

Current
Registration Yr

Centre de distribution Coloplast Le Plessis Pate

FRANCE

3012649202

2024

catheter, nephrostomy, general & plastic surgery - Chiba needle

Repackager/Relabeler

cystoscope and accessories, flexible/rigid - Isiris™ a; Isiris™ Monitor; Isiris™ Monitor Fixture; Isiris™ Monitor adaptor kit type G; Isiris™ Monitor adaptor kit-typ

Foreign Exporter

stent, ureteral

Foreign Exporter

catheter, nephrostomy - In-Ka Percutaneous Balloon Catheter and Amplatz Sheath

Foreign Exporter

dilator, catheter, ureteral - In-Ka® Ureteral Balloon Dilatation Catheters

Foreign Exporter

Show all 25 Listings for Centre de distribution Coloplast Le Plessis Pate FRANCE

COLOPLAST (CHINA) LTD.

CHINA

3005945907

2024

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

Manufacturer

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 Skin Barrier Spray; Brava Skin Barrier Wipe; Brava Skin Cleanser; 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, non-sterile - Coloplast Bedside Drainage Bag; Conveen Active; Conveen Contour; Conveen Leg Bag Strap; Conveen Security+; Conveen Standard; Conveen Urine Bag Hanger

Manufacturer

bag, urine collection, leg, for external use, sterile - Conveen Contour; Conveen Security+

Manufacturer

catheter, straight - Self-Cath; Self-Cath Plus

Manufacturer

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 Skin Barrier Spray; Brava Skin Barrier Wipe; Brava Skin Cleanser; 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

Show all 35 Listings for COLOPLAST A/S DENMARK

Coloplast A/S - Mordrup Site

DENMARK

3011307048

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 Skin Barrier Spray; Brava Skin Barrier Wipe; Brava Skin Cleanser; 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

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

Manufacturer

Coloplast Corp.

TX/USA

3030087693

2024

Coloplast Costa Rica SA

COSTA RICA

3015131144

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 Skin Barrier Spray; Brava Skin Barrier Wipe; Brava Skin Cleanser; 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

catheter, urethral - SpeediCath Standard

Manufacturer

catheter, urethral - SpeediCath Flex Coude Pro

Manufacturer

catheter, urethral - SpeediCath Soft

Manufacturer

catheter, urethral - SpeediCath Flex Coude Pro

Manufacturer

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 Skin Barrier Spray; Brava Skin Barrier Wipe; Brava Skin Cleanser; 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

Show all 17 Listings for COLOPLAST HUNGARY KFT HUNGARY

COLOPLAST HUNGARY KFT

HUNGARY

3006606901

2024

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

Manufacturer

dressing, wound, drug - Biatain Ag Adhesive; Biatain Ag Non-Adhesive

Manufacturer

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

Contract Manufacturer; Manufacturer

catheter, urethral - SpeediCath Flex Coude Pro

Manufacturer

catheter, urethral - SpeediCath Standard

Manufacturer

Show all 21 Listings for COLOPLAST HUNGARY KFT HUNGARY

Coloplast Hungary, KFT

HUNGARY

3008262278

2024

bag, urine collection, leg, for external use, sterile - Conveen Contour; Conveen Security+

Repackager/Relabeler

bag, drainage, with adhesive, ostomy - COLOPLAST FISTULA AND WOUND MANAGAMENT SYSTEM; Coloplast Fistula Bed Drainage Bag; Coloplast Flexible Lid

Repackager/Relabeler

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 Skin Barrier Spray; Brava Skin Barrier Wipe; Brava Skin Cleanser; 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

Repackager/Relabeler

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

Repackager/Relabeler

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

Repackager/Relabeler

Show all 15 Listings for Coloplast Hungary, KFT HUNGARY

COLOPLAST MANUFACTURING FRANCE, SAS

FRANCE

9610711

2024

catheter, nephrostomy, general & plastic surgery - Chiba needle

Manufacturer

dislodger, stone, basket, ureteral, metal - Dormia DualPerc; Dormia No Tip; Dornia N-Stone

Manufacturer

lavage, jet - ELEFANT (TM) Suction-Irrigation Device

Manufacturer

catheter, retention type, balloon - X-flow

Manufacturer

catheter, retention type, balloon - Folysil

Manufacturer

Show all 24 Listings for COLOPLAST MANUFACTURING FRANCE, SAS FRANCE

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Establishment Registration & Device Listing

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