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 05701780334402 Coloplast A/S	ImaJin AJ4C65	2024-04-22
GUDID 05701780334372 Coloplast A/S	ImaJin AJ4C64	2024-04-22
GUDID 05701780334341 Coloplast A/S	ImaJin AJ4C63	2024-04-22
GUDID 05701780334310 Coloplast A/S	ImaJin AJ4C62	2024-04-22
GUDID 05701780334297 Coloplast A/S	ImaJin AJ4286	2024-04-22
GUDID 05701780334259 Coloplast A/S	ImaJin AJ4285	2024-04-22
GUDID 05701780334235 Coloplast A/S	ImaJin AJ4284	2024-04-22
GUDID 05701780334198 Coloplast A/S	ImaJin AJ4283	2024-04-22
GUDID 05701780334174 Coloplast A/S	ImaJin AJ4282	2024-04-22
GUDID 05701780334136 Coloplast A/S	ImaJin AJ4281	2024-04-22
GUDID 05701780334112 Coloplast A/S	ImaJin AJ4276	2024-04-22
GUDID 05701780334075 Coloplast A/S	ImaJin AJ4275	2024-04-22
GUDID 05701780334044 Coloplast A/S	ImaJin AJ4274	2024-04-22
GUDID 05701780334020 Coloplast A/S	ImaJin AJ4273	2024-04-22
GUDID 05701780333993 Coloplast A/S	ImaJin AJ4272	2024-04-22
GUDID 05701780333962 Coloplast A/S	ImaJin AJ4271	2024-04-22
GUDID 05701780333924 Coloplast A/S	ImaJin AJ4266	2024-04-22
GUDID 05701780333900 Coloplast A/S	ImaJin AJ4265	2024-04-22
GUDID 05701780333870 Coloplast A/S	ImaJin AJ4264	2024-04-22
GUDID 05701780333849 Coloplast A/S	ImaJin AJ4263	2024-04-22
GUDID 05701780333818 Coloplast A/S	ImaJin AJ4262	2024-04-22
GUDID 05701780333788 Coloplast A/S	ImaJin AJ4261	2024-04-22
GUDID 05701780333757 Coloplast A/S	Vortek ACBM86	2024-04-22
GUDID 05701780333719 Coloplast A/S	Vortek ACBM85	2024-04-22
GUDID 05701780333696 Coloplast A/S	Vortek ACBM84	2024-04-22
GUDID 05701780333658 Coloplast A/S	Vortek ACBM83	2024-04-22
GUDID 05701780333627 Coloplast A/S	Vortek ACBM77	2024-04-22
GUDID 05701780333603 Coloplast A/S	Vortek ACBM76	2024-04-22
GUDID 05701780333566 Coloplast A/S	Vortek ACBM75	2024-04-22
GUDID 05701780333535 Coloplast A/S	Vortek ACBM74	2024-04-22
GUDID 05701780333504 Coloplast A/S	Vortek ACBM73	2024-04-22
GUDID 05701780333481 Coloplast A/S	Vortek ACBM72	2024-04-22
GUDID 05701780333450 Coloplast A/S	Vortek ACBM67	2024-04-22
GUDID 05701780333412 Coloplast A/S	Vortek ACBM66	2024-04-22
GUDID 05701780333382 Coloplast A/S	Vortek ACBM65	2024-04-22
GUDID 05701780333368 Coloplast A/S	Vortek ACBM64	2024-04-22
GUDID 05701780333337 Coloplast A/S	Vortek ACBM63	2024-04-22
GUDID 05701780333290 Coloplast A/S	Vortek ACBM62	2024-04-22
GUDID 05701780333276 Coloplast A/S	Vortek ACBM57	2024-04-22
GUDID 05701780333245 Coloplast A/S	Vortek ACBM56	2024-04-22
GUDID 05701780333214 Coloplast A/S	Vortek ACBM55	2024-04-22
GUDID 05701780333177 Coloplast A/S	Vortek ACBM54	2024-04-22
GUDID 05701780333092 Coloplast A/S	Vortek ACBM53	2024-04-22
GUDID 05701780333054 Coloplast A/S	Vortek ACBM52	2024-04-22
GUDID 05701780333016 Coloplast A/S	Vortek ACBM51	2024-04-22
GUDID 05701780332934 Coloplast A/S	Vortek ACBM50	2024-04-22
GUDID 05701780332903 Coloplast A/S	Vortek ACB1C7	2024-04-22
GUDID 05701780332880 Coloplast A/S	Vortek ACB1C5	2024-04-22
GUDID 05701780332859 Coloplast A/S	Vortek ACB1C4	2024-04-22
GUDID 05701780332811 Coloplast A/S	Vortek ACB1C3	2024-04-22
GUDID 05701780332781 Coloplast A/S	Vortek ACB1C2	2024-04-22
GUDID 05701780332750 Coloplast A/S	Vortek ACB1C1	2024-04-22
GUDID 05701780332729 Coloplast A/S	Vortek ACB1C0	2024-04-22
GUDID 05701780332699 Coloplast A/S	Vortek ACB186	2024-04-22
GUDID 05701780332668 Coloplast A/S	Vortek ACB185	2024-04-22
GUDID 05701780332637 Coloplast A/S	Vortek ACB184	2024-04-22
GUDID 05701780332606 Coloplast A/S	Vortek ACB183	2024-04-22
GUDID 05701780332569 Coloplast A/S	Vortek ACB177	2024-04-22
GUDID 05701780332545 Coloplast A/S	Vortek ACB176	2024-04-22
GUDID 05701780332491 Coloplast A/S	Vortek ACB175	2024-04-22
GUDID 05701780332422 Coloplast A/S	Vortek ACB174	2024-04-22
GUDID 05701780332330 Coloplast A/S	Vortek ACB173	2024-04-22
GUDID 05701780332316 Coloplast A/S	Vortek ACB172	2024-04-22
GUDID 05701780332279 Coloplast A/S	Vortek ACB167	2024-04-22
GUDID 05701780332231 Coloplast A/S	Vortek ACB166	2024-04-22
GUDID 05701780332200 Coloplast A/S	Vortek ACB165	2024-04-22
GUDID 05701780332187 Coloplast A/S	Vortek ACB164	2024-04-22
GUDID 05701780332149 Coloplast A/S	Vortek ACB163	2024-04-22
GUDID 05701780332101 Coloplast A/S	Vortek ACB162	2024-04-22
GUDID 03600040967119 Coloplast A/S	Coloplast ACP607	2024-04-22
GUDID 03600040967027 Coloplast A/S	Coloplast ACP606	2024-04-22
GUDID 03600040966976 Coloplast A/S	Coloplast ACP605	2024-04-22
GUDID 03600040966877 Coloplast A/S	Coloplast ACP604	2024-04-22
GUDID 03600040966822 Coloplast A/S	Coloplast ACP603	2024-04-22
GUDID 03600040966761 Coloplast A/S	Coloplast ACP407	2024-04-22
GUDID 03600040966709 Coloplast A/S	Coloplast ACP406	2024-04-22
GUDID 03600040966631 Coloplast A/S	Coloplast ACP405	2024-04-22
GUDID 03600040966570 Coloplast A/S	Coloplast ACP404	2024-04-22
GUDID 03600040966518 Coloplast A/S	Coloplast ACP403	2024-04-22
GUDID 03600040966457 Coloplast A/S	Coloplast ACP307	2024-04-22
GUDID 03600040966365 Coloplast A/S	Coloplast ACP306	2024-04-22
GUDID 03600040966280 Coloplast A/S	Coloplast ACP305	2024-04-22
GUDID 03600040966198 Coloplast A/S	Coloplast ACP304	2024-04-22
GUDID 03600040966105 Coloplast A/S	Coloplast ACP303	2024-04-22
GUDID 03600040966037 Coloplast A/S	Coloplast ACP208	2024-04-22
GUDID 03600040965979 Coloplast A/S	Coloplast ACP207	2024-04-22
GUDID 03600040965924 Coloplast A/S	Coloplast ACP206	2024-04-22
GUDID 03600040965863 Coloplast A/S	Coloplast ACP205	2024-04-22
GUDID 03600040964385 Coloplast A/S	Coloplast AC5912	2024-04-22
GUDID 03600040964323 Coloplast A/S	Coloplast AC5911	2024-04-22
GUDID 03600040964262 Coloplast A/S	Coloplast AC5910	2024-04-22
GUDID 03600040964200 Coloplast A/S	Coloplast AC5909	2024-04-22
GUDID 03600040964156 Coloplast A/S	Coloplast AC5908	2024-04-22
GUDID 03600040964057 Coloplast A/S	Coloplast AC5907	2024-04-22
GUDID 03600040963999 Coloplast A/S	Coloplast AC5906	2024-04-22
GUDID 03600040963913 Coloplast A/S	Coloplast AC5905	2024-04-22
GUDID 03600040963845 Coloplast A/S	Coloplast AC5904	2024-04-22
GUDID 03600040953747 Coloplast A/S	Coloplast RBA012	2024-04-22
GUDID 03600040953716 Coloplast A/S	Coloplast RBA010	2024-04-22
GUDID 03600040953693 Coloplast A/S	Coloplast RBA008	2024-04-22
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