Coloplast A S

FDA Filings

This page includes the latest FDA filings for Coloplast A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

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COLO B

DUNS 305524696

FDA Registration(s)

FDA Filings

Device Company	Device	Date
GUDID 05708932769426 Coloplast A/S	Biatain Fiber 33508	2024-12-20
GUDID 05708932769396 Coloplast A/S	Biatain Fiber 33506	2024-12-20
GUDID 05708932769365 Coloplast A/S	Biatain Fiber 33504	2024-12-20
GUDID 05708932769334 Coloplast A/S	Biatain Fiber 33501	2024-12-20
GUDID 05708932764582 Coloplast A/S	Biatain Fiber Ag 33570	2024-12-02
GUDID 05708932764568 Coloplast A/S	Biatain Fiber Ag 33576	2024-12-02
GUDID 05708932764551 Coloplast A/S	Biatain Fiber Ag 33574	2024-12-02
GUDID 05708932764520 Coloplast A/S	Biatain Fiber Ag 33578	2024-12-02
GUDID 05708932764490 Coloplast A/S	Biatain Fiber Ag 33572	2024-12-02
GUDID 03600040995389 Coloplast A/S	ReTrace AXXL12	2024-11-28
GUDID 03600040995341 Coloplast A/S	ReTrace AXXL10	2024-11-28
GUDID 03600040995310 Coloplast A/S	ReTrace ASXL12	2024-11-28
GUDID 03600040995280 Coloplast A/S	ReTrace ASXL10	2024-11-28
GUDID 03600040995259 Coloplast A/S	ReTrace ALXL12	2024-11-28
GUDID 03600040995235 Coloplast A/S	ReTrace ALXL10	2024-11-28
GUDID 03600040995198 Coloplast A/S	ReTrace ACXL12	2024-11-28
GUDID 03600040995167 Coloplast A/S	ReTrace ACXL10	2024-11-28
GUDID 05708932768177 Coloplast A/S	Titan Touch ES2924	2024-11-06
GUDID 05708932768153 Coloplast A/S	Titan Touch ES2824	2024-11-06
GUDID 05708932768139 Coloplast A/S	Titan Classic ES8924	2024-11-06
GUDID 05708932768115 Coloplast A/S	Titan Classic ES8824	2024-11-06
GUDID 05708932020558 Coloplast A/S	SpeediCath Compact 28580	2024-11-05
GUDID 05701780272186 Coloplast A/S	Kolibri RMA214	2024-10-07
GUDID 05701780272155 Coloplast A/S	Kolibri RMA212	2024-10-07
GUDID 05701780272131 Coloplast A/S	Kolibri RMA210	2024-10-07
GUDID 05701780272100 Coloplast A/S	Kolibri RMA208	2024-10-07
GUDID 05701780272063 Coloplast A/S	Kolibri RMA114	2024-10-07
GUDID 05701780272049 Coloplast A/S	Kolibri RMA112	2024-10-07
GUDID 05701780272001 Coloplast A/S	Kolibri RMA110	2024-10-07
GUDID 05701780271974 Coloplast A/S	Kolibri RMA108	2024-10-07
GUDID 05701780271950 Coloplast A/S	Kolibri RJB210	2024-10-07
GUDID 05701780271912 Coloplast A/S	Kolibri RJB208	2024-10-07
GUDID 05701780271875 Coloplast A/S	Kolibri RJB110	2024-10-07
GUDID 05701780271851 Coloplast A/S	Kolibri RJB109	2024-10-07
GUDID 05701780271813 Coloplast A/S	Kolibri RJB108	2024-10-07
GUDID 05701780271783 Coloplast A/S	Kolibri RJB007	2024-10-07
GUDID 05701780271745 Coloplast A/S	Kolibri RJB006	2024-10-07
GUDID 05701780271714 Coloplast A/S	Kolibri RJA212	2024-10-07
GUDID 05701780271677 Coloplast A/S	Kolibri RJA210	2024-10-07
GUDID 05701780271646 Coloplast A/S	Kolibri RJA208	2024-10-07
GUDID 05701780271622 Coloplast A/S	Kolibri RJA114	2024-10-07
GUDID 05701780271592 Coloplast A/S	Kolibri RJA112	2024-10-07
GUDID 05701780271547 Coloplast A/S	Kolibri RJA110	2024-10-07
GUDID 05701780271509 Coloplast A/S	Kolibri RJA108	2024-10-07
GUDID 05701780271462 Coloplast A/S	Kolibri RJA008	2024-10-07
GUDID 05701780271448 Coloplast A/S	Kolibri RJA006	2024-10-07
GUDID 05701780271417 Coloplast A/S	Kolibri RCM014	2024-10-07
GUDID 05701780271363 Coloplast A/S	Kolibri RCM012	2024-10-07
GUDID 05701780271332 Coloplast A/S	Kolibri RCM010	2024-10-07
GUDID 05701780271318 Coloplast A/S	Kolibri RCM008	2024-10-07
GUDID 05701780271271 Coloplast A/S	Kolibri RCJ114	2024-10-07
GUDID 05701780271240 Coloplast A/S	Kolibri RCJ112	2024-10-07
GUDID 05701780271219 Coloplast A/S	Kolibri RCJ110	2024-10-07
GUDID 05701780271189 Coloplast A/S	Kolibri RCJ109	2024-10-07
GUDID 05701780271165 Coloplast A/S	Kolibri RCJ108	2024-10-07
GUDID 05701780271127 Coloplast A/S	Kolibri RCJ008	2024-10-07
GUDID 05701780271097 Coloplast A/S	Kolibri RCJ007	2024-10-07
GUDID 05701780271066 Coloplast A/S	Kolibri RCJ006	2024-10-07
GUDID 05701780271042 Coloplast A/S	Kolibri RJD110	2024-10-07
GUDID 05701780270977 Coloplast A/S	Kolibri RJD108	2024-10-07
GUDID 05701780270939 Coloplast A/S	Kolibri RCM020	2024-10-07
GUDID 05701780270908 Coloplast A/S	Kolibri RCM018	2024-10-07
GUDID 05701780270878 Coloplast A/S	Kolibri RCM016	2024-10-07
GUDID 03600040272930 Coloplast A/S	Porges Coloplast NBI070	2024-10-07
GUDID 03600040272916 Coloplast A/S	Porges Coloplast NBI035	2024-10-07
GUDID 03600040146415 Coloplast A/S	Porges Coloplast AB6C22	2024-10-07
GUDID 03600040146316 Coloplast A/S	Porges Coloplast AB6C18	2024-10-07
GUDID 03600040144190 Coloplast A/S	Porges Coloplast AB6318	2024-10-07
GUDID 03600040144091 Coloplast A/S	Porges Coloplast AB6222	2024-10-07
GUDID 03600040143902 Coloplast A/S	Porges Coloplast AB6124	2024-10-07
GUDID 05708932556576 Coloplast A/S	Coloplast 95050	2024-09-02
GUDID 03600040145760 Coloplast A/S	Porges Coloplast AB6724	2024-08-30
GUDID 03600040145692 Coloplast A/S	Porges Coloplast AB6722	2024-08-30
GUDID 03600040145623 Coloplast A/S	Porges Coloplast AB6720	2024-08-30
GUDID 03600040145555 Coloplast A/S	Porges Coloplast AB6718	2024-08-30
GUDID 03600040145487 Coloplast A/S	Porges Coloplast AB6624	2024-08-30
GUDID 03600040145418 Coloplast A/S	Porges Coloplast AB6622	2024-08-30
GUDID 03600040145340 Coloplast A/S	Porges Coloplast AB6620	2024-08-30
GUDID 03600040145272 Coloplast A/S	Porges Coloplast AB6618	2024-08-30
GUDID 03600040145203 Coloplast A/S	Porges Coloplast AB6524	2024-08-30
GUDID 03600040145135 Coloplast A/S	Porges Coloplast AB6522	2024-08-30
GUDID 03600040145067 Coloplast A/S	Porges Coloplast AB6520	2024-08-30
GUDID 03600040144992 Coloplast A/S	Porges Coloplast AB6518	2024-08-30
GUDID 03600040144923 Coloplast A/S	Porges Coloplast AB6424	2024-08-30
GUDID 03600040144855 Coloplast A/S	Porges Coloplast AB6422	2024-08-30
GUDID 03600040144787 Coloplast A/S	Porges Coloplast AB6420	2024-08-30
GUDID 03600040144718 Coloplast A/S	Porges Coloplast AB6418	2024-08-30
GUDID 03600040144589 Coloplast A/S	Porges Coloplast AB6324	2024-08-30
GUDID 03600040144459 Coloplast A/S	Porges Coloplast AB6322	2024-08-30
GUDID 03600040144329 Coloplast A/S	Porges Coloplast AB6320	2024-08-30
GUDID 03600040144145 Coloplast A/S	Porges Coloplast AB6224	2024-08-30
GUDID 03600040144046 Coloplast A/S	Porges Coloplast AB6220	2024-08-30
GUDID 03600040143995 Coloplast A/S	Porges Coloplast AB6218	2024-08-30
GUDID 03600040143810 Coloplast A/S	Porges Coloplast AB6122	2024-08-30
GUDID 03600040143728 Coloplast A/S	Porges Coloplast AB6120	2024-08-30
GUDID 03600040143636 Coloplast A/S	Porges Coloplast AB6118	2024-08-30
GUDID 03600040143506 Coloplast A/S	Porges Coloplast AB6024	2024-08-30
GUDID 03600040143377 Coloplast A/S	Porges Coloplast AB6022	2024-08-30
GUDID 03600040143247 Coloplast A/S	Porges Coloplast AB6020	2024-08-30
GUDID 03600040143117 Coloplast A/S	Porges Coloplast AB6018	2024-08-30
PMN K220420 Coloplast A/S	Saffron Fixation System	2022-06-10
PMN K191536 Coloplast A/S	Biatain Silicone Ag	2020-02-21
PMN K181811 Coloplast A/S	ReTrace Ureteral Access Sheath	2018-09-07
PMN K173527 Coloplast A/S	Digitex Delivery Device	2018-02-12
PMN K140310 COLOPLAST A/S	Peristeen Anal Irrigation System	2015-09-03
PMN K150935 COLOPLAST A/S	SpeediCath Compact Eve	2015-07-02
PMN K150927 COLOPLAST A/S	Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic Guidewire Angled Stiff,Orchestra Hydrophilic Guidewire Standard Straight, Orchestra Hydrophilic Guidewire Straight Stiff	2015-05-27
PMN K143182 COLOPLAST A/S	Speedicath Compact Male	2015-01-20
PMN K140523 COLOPLAST A/S	RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM	2014-07-24
PMN K140116 COLOPLAST A/S	RESTORELLE Y CONTOUR MESH	2014-02-12
PMN K131072 COLOPLAST A/S	ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC	2013-07-09
PMN K123914 COLOPLAST A/S	RESTORELLE Y CONTOUR	2013-03-05
PMN K123675 COLOPLAST A/S	RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR	2013-03-01
PMN K121562 COLOPLAST A/S	ALTIS SINGLE INCISION CLING SYSTEM	2012-11-05
PMN K121458 COLOPLAST A/S	SPEEDICATH COMPACT SET (12/18 FR)	2012-10-01
PMN K121833 COLOPLAST A/S	OSTOMY IRRIGATION SET	2012-07-16
PMN K112860 COLOPLAST A/S	PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER	2012-06-08
PMN K120284 COLOPLAST A/S	DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX	2012-05-23
PMN K112322 COLOPLAST A/S	RESTORELLE POLYPROPYLENE Y MESH	2012-05-17
PMN K120828 COLOPLAST A/S	BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES	2012-04-05
PMN K113496 COLOPLAST A/S	VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT	2012-02-14
PMN K111881 COLOPLAST A/S	VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT	2011-08-17
PMN K111233 COLOPLAST A/S	SUPRIS RETROPUBIC SLING SYSTEM	2011-06-24
PMN K103254 COLOPLAST A/S	PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE	2011-01-31
PMN K103568 COLOPLAST A/S	RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH	2010-12-22
PMN K102485 COLOPLAST A/S	RE-TRACE URETERAL ACCESS SHEATH	2010-10-18
PMN K101297 COLOPLAST A/S	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020	2010-06-03
PMN K100218 COLOPLAST A/S	BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM	2010-02-17
PMN K083770 COLOPLAST A/S	COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM	2009-11-23
PMN K083499 COLOPLAST A/S	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS	2009-05-08
PMN K091152 COLOPLAST A/S	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020	2009-05-07
PMN K090217 COLOPLAST A/S	BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070	2009-04-23
PMN K953497 COLOPLAST A/S	COMFEEL:ALGINATE DRESSING	1995-09-29
PMN K946243 COLOPLAST A/S	CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER	1995-02-13
PMN K925376 COLOPLAST A/S	COMFEEL(R) WOUND DRESSING SD	1993-03-16
PMN K924406 COLOPLAST A/S	CONVEEN(R) LEG BAG(500 ML)	1992-10-30
PMN K924407 COLOPLAST A/S	CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH	1992-09-23
PMN K922466 COLOPLAST A/S	COMFEEL WOUND DRESSING SD	1992-08-17
PMN K922461 COLOPLAST A/S	COMFEEL WOUND DRESSING ORD	1992-08-17
PMN K920925 COLOPLAST A/S	COMFEEL CONTOUR DRESSING	1992-05-28
PMN K915246 COLOPLAST A/S	CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)	1992-02-05
PMN K904085 COLOPLAST A/S	ELLA BREAST FORM	1990-10-31
PMN K904086 COLOPLAST A/S	DISCRENE SELF-SUPPORTING BREAST FORM	1990-10-02
PMN K895548 COLOPLAST A/S	CONVEEN INTERMITTENT CATHETERS	1990-02-09
PMN K894916 COLOPLAST A/S	COMFEEL TRANSPARENT DRESSING	1989-09-26
PMN K883588 COLOPLAST A/S	COMPEED ATHLETIC DRESSING	1988-09-22
PMN K881636 COLOPLAST A/S	CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)	1988-07-13
PMN K873669 COLOPLAST A/S	COMFEEL ULCUS ULCER CARE SYSTEM	1987-11-17
PMN K871643 COLOPLAST A/S	CONVEEN(R) LEG-BAG (600 ML)	1987-06-10
PMN K871610 COLOPLAST A/S	CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)	1987-06-10
PMN K863830 COLOPLAST A/S	CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM	1986-10-16
PMN K861070 COLOPLAST A/S	COLOPLAST CONVEX RING	1986-06-16
PMN K854580 COLOPLAST A/S	CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH	1985-12-13
PMN K844685 COLOPLAST A/S	COLOPLAST URO 2002 UROSTOMY SYSTEM	1985-01-08
PMN K844684 COLOPLAST A/S	COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM	1985-01-08
PMN K834343 COLOPLAST A/S	COMFEEL POWDER	1984-11-08
PMN K840438 COLOPLAST A/S	COMFEEL ULCUS SHEET	1984-11-07
PMN K840362 COLOPLAST A/S	COMFEEL PASTE	1984-11-07
PMN K833567 COLOPLAST A/S	COMFEEL PROTECTIVE FILM	1984-05-02
PMN K840268 COLOPLAST A/S	IRRIGATION SYSTEM	1984-04-05
PMN K840269 COLOPLAST A/S	MC 2000 OSTOMY POUCHES	1984-04-02
PMN K840267 COLOPLAST A/S	FILTRODER FILTERS	1984-04-02
PMN K840265 COLOPLAST A/S	MC 2002 OSTOMY POUCHES & SKIN FLANGES	1984-04-02
PMN K833571 COLOPLAST A/S	STERILE DRAINAGE SYSTEM	1984-01-30
PMN K833570 COLOPLAST A/S	COLOPLAST BABY URINE COLLECTORS	1984-01-30
PMN K833565 COLOPLAST A/S	COMFEEL PASTE	1984-01-30
PMN K840266 COLOPLAST A/S	K-FLEX OSTOMY POUCH	1984-01-23
PMN K833569 COLOPLAST A/S	COMFEEL BARRIER CREAM	1983-12-27
PMN K833566 COLOPLAST A/S	COMFEEL CLEANSER	1983-12-27
PMN K832908 COLOPLAST A/S	COMFEEL PROTECTIVE RINGS	1983-12-12

Similar & Related FDA Registered Companies

COLOPLAST MANUFACTURING US, LLC
COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS065 Date Received12/16/2022 Decision Date01/12/2023 Product Code FHW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS063 Date Received11/02/2022 Decision Date12/01/2022 Product Code FHW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP020003 Supplement NumberS011 Date Received08/17/2022 Decision Date09/16/2022 Product Code FAF Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS062 Date Received07/27/2022 Decision Date08/24/2022 Product Code FHW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP020003 Supplement NumberS010 Date Received07/27/2022 Decision Date08/24/2022 Product Code FAF Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS061 Date Received03/16/2022 Decision Date04/15/2022 Product Code FHW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	R3199	COLOPLAST A/S
CAGE Code	R3199	COLOPLAST A/S
SEC	0001294323	COLOPLAST A/S
SEC	0001294325	COLOPLAST A/S

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200929102255	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	TAPE AND BANDAGES ON 40 PALLET S REF: 376771 + 376772 INVO ICE NO: 19063906 / RI; 1906390 7 / RI JNJ PO NO: 451530977, 451530983 CONTRACT NO: US036- 11 NET: 2833,068,- KG HS COD E: 3005.10.00 SEAL : MBX09825	5039 PKG
2020092839885	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	25 PKG
2020092856409	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	31 PKG
2020092841426	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	31 PKG
2020092847799	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	1764 PKG
2020092847799	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	1764 PKG
2020092858120	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	31 PKG
2020092842168	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	31 PKG
2020092841488	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	31 PKG