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 05701780286831 Coloplast A/S	Luja 20056	2024-08-14
GUDID 05701780286800 Coloplast A/S	Luja 20054	2024-08-14
GUDID 05701780286794 Coloplast A/S	Luja 20052	2024-08-14
GUDID 05701780286763 Coloplast A/S	Luja 20051	2024-08-14
GUDID 03600040996935 Coloplast A/S	Folysil AA6624	2024-07-22
GUDID 03600040996904 Coloplast A/S	Folysil AA6618	2024-07-22
GUDID 03600040996874 Coloplast A/S	Folysil AA6612	2024-07-22
GUDID 03600040996850 Coloplast A/S	Folysil AA6522	2024-07-22
GUDID 03600040996836 Coloplast A/S	Folysil AA6518	2024-07-22
GUDID 03600040996812 Coloplast A/S	Folysil AA6514	2024-07-22
GUDID 03600040996805 Coloplast A/S	Folysil AA6512	2024-07-22
GUDID 03600040996744 Coloplast A/S	Folysil AA6414	2024-07-22
GUDID 03600040996690 Coloplast A/S	Folysil AA6324	2024-07-22
GUDID 03600040996669 Coloplast A/S	Folysil AA6318	2024-07-22
GUDID 03600040996645 Coloplast A/S	Folysil AA6314	2024-07-22
GUDID 03600040996614 Coloplast A/S	Folysil AA6308	2024-07-22
GUDID 03600040996607 Coloplast A/S	Folysil AA6124	2024-07-22
GUDID 03600040996577 Coloplast A/S	Folysil AA6118	2024-07-22
GUDID 03600040996522 Coloplast A/S	Folysil AA6108	2024-07-22
GUDID 03600040996508 Coloplast A/S	Folysil AA6C24	2024-07-22
GUDID 03600040996492 Coloplast A/S	Folysil AA6C22	2024-07-22
GUDID 03600040996485 Coloplast A/S	Folysil AA6C20	2024-07-22
GUDID 03600040996478 Coloplast A/S	Folysil AA6C18	2024-07-22
GUDID 03600040996454 Coloplast A/S	Folysil AA6622	2024-07-22
GUDID 03600040996447 Coloplast A/S	Folysil AA6620	2024-07-22
GUDID 03600040996423 Coloplast A/S	Folysil AA6616	2024-07-22
GUDID 03600040996416 Coloplast A/S	Folysil AA6614	2024-07-22
GUDID 03600040996393 Coloplast A/S	Folysil AA6524	2024-07-22
GUDID 03600040996379 Coloplast A/S	Folysil AA6520	2024-07-22
GUDID 03600040996355 Coloplast A/S	Folysil AA6516	2024-07-22
GUDID 03600040996324 Coloplast A/S	Folysil AA6424	2024-07-22
GUDID 03600040996317 Coloplast A/S	Folysil AA6422	2024-07-22
GUDID 03600040996300 Coloplast A/S	Folysil AA6420	2024-07-22
GUDID 03600040996294 Coloplast A/S	Folysil AA6418	2024-07-22
GUDID 03600040996287 Coloplast A/S	Folysil AA6416	2024-07-22
GUDID 03600040996263 Coloplast A/S	Folysil AA6412	2024-07-22
GUDID 03600040996256 Coloplast A/S	Folysil AA6410	2024-07-22
GUDID 03600040996249 Coloplast A/S	Folysil AA6408	2024-07-22
GUDID 03600040996232 Coloplast A/S	Folysil AA6406	2024-07-22
GUDID 03600040996218 Coloplast A/S	Folysil AA6322	2024-07-22
GUDID 03600040996201 Coloplast A/S	Folysil AA6320	2024-07-22
GUDID 03600040996188 Coloplast A/S	Folysil AA6316	2024-07-22
GUDID 03600040996164 Coloplast A/S	Folysil AA6312	2024-07-22
GUDID 03600040996157 Coloplast A/S	Folysil AA6310	2024-07-22
GUDID 03600040996126 Coloplast A/S	Folysil AA6122	2024-07-22
GUDID 03600040996119 Coloplast A/S	Folysil AA6120	2024-07-22
GUDID 03600040996096 Coloplast A/S	Folysil AA6116	2024-07-22
GUDID 03600040996089 Coloplast A/S	Folysil AA6114	2024-07-22
GUDID 03600040996072 Coloplast A/S	Folysil AA6112	2024-07-22
GUDID 03600040996065 Coloplast A/S	Folysil AA6110	2024-07-22
GUDID 03600040996041 Coloplast A/S	Folysil AA6106	2024-07-22
GUDID 03600040975367 Coloplast A/S	Coloplast RBD014	2024-07-17
GUDID 03600040975336 Coloplast A/S	Coloplast RBD010	2024-07-17
GUDID 03600040229798 Coloplast A/S	Porges Coloplast EFP634	2024-07-12
GUDID 03600040229729 Coloplast A/S	Porges Coloplast EFP624	2024-07-12
GUDID 03600040229675 Coloplast A/S	Porges Coloplast EFP434	2024-07-12
GUDID 03600040229620 Coloplast A/S	Porges Coloplast EFP424	2024-07-12
GUDID 03600040228548 Coloplast A/S	Porges Coloplast DOV224	2024-07-12
GUDID 03600040228180 Coloplast A/S	Porges Coloplast DOR634	2024-07-12
GUDID 03600040228098 Coloplast A/S	Porges Coloplast DOR624	2024-07-12
GUDID 03600040227589 Coloplast A/S	Porges Coloplast DOR434	2024-07-12
GUDID 03600040227497 Coloplast A/S	Porges Coloplast DOR424	2024-07-12
GUDID 03600040226476 Coloplast A/S	Porges Coloplast DOR117	2024-07-12
GUDID 03600040226407 Coloplast A/S	Porges Coloplast DOR116	2024-07-12
GUDID 03600040226339 Coloplast A/S	Porges Coloplast DOR115	2024-07-12
GUDID 03600040226261 Coloplast A/S	Porges Coloplast DOR114	2024-07-12
GUDID 03600040226032 Coloplast A/S	Porges Coloplast DOR111	2024-07-12
GUDID 03600040197042 Coloplast A/S	Porges Coloplast AH5608	2024-07-12
GUDID 03600040196960 Coloplast A/S	Porges Coloplast AH5406	2024-07-12
GUDID 03600040196878 Coloplast A/S	Porges Coloplast AH5312	2024-07-12
GUDID 03600040196786 Coloplast A/S	Porges Coloplast AH5308	2024-07-12
GUDID 03600040196694 Coloplast A/S	Porges Coloplast AH5212	2024-07-12
GUDID 03600040196601 Coloplast A/S	Porges Coloplast AH5110	2024-07-12
GUDID 03600040196519 Coloplast A/S	Porges Coloplast AH5108	2024-07-12
GUDID 03600040196427 Coloplast A/S	Porges Coloplast AH5106	2024-07-12
GUDID 03600040196359 Coloplast A/S	Porges Coloplast AH5010	2024-07-12
GUDID 03600040195925 Coloplast A/S	Porges Coloplast AH4212	2024-07-12
GUDID 03600040195741 Coloplast A/S	Porges Coloplast AH24M9	2024-07-12
GUDID 03600040195697 Coloplast A/S	Porges Coloplast AH24F8	2024-07-12
GUDID 03600040195598 Coloplast A/S	Porges Coloplast AH2108	2024-07-12
GUDID 03600040953808 Coloplast A/S	Coloplast RBB014	2024-05-29
GUDID 03600040911105 Coloplast A/S	Coloplast RBC010	2024-05-29
GUDID 03600040911068 Coloplast A/S	Coloplast RBC008	2024-05-29
GUDID 03600040953785 Coloplast A/S	Coloplast RBB010	2024-05-20
GUDID 05701780341851 Coloplast A/S	SenSura Mio Convex 16891	2024-04-29
GUDID 05701780341820 Coloplast A/S	SenSura Mio Convex 16890	2024-04-29
GUDID 05701780341790 Coloplast A/S	SenSura Mio Convex 16889	2024-04-29
GUDID 05701780341769 Coloplast A/S	SenSura Mio Convex 16888	2024-04-29
GUDID 05701780341738 Coloplast A/S	SenSura Mio Convex 16887	2024-04-29
GUDID 05701780341707 Coloplast A/S	SenSura Mio Convex 16886	2024-04-29
GUDID 05701780341677 Coloplast A/S	SenSura Mio Convex 16885	2024-04-29
GUDID 05701780341646 Coloplast A/S	SenSura Mio Convex 16884	2024-04-29
GUDID 05701780341615 Coloplast A/S	SenSura Mio Convex 16883	2024-04-29
GUDID 05701780341585 Coloplast A/S	SenSura Mio Convex 16882	2024-04-29
GUDID 05701780341554 Coloplast A/S	SenSura Mio Convex 16881	2024-04-29
GUDID 05701780341523 Coloplast A/S	SenSura Mio Convex 16880	2024-04-29
GUDID 03600040926628 Coloplast A/S	Coloplast AE1138	2024-04-29
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