FDA.report

COLOPLAST MANUFACTURING US, LLC

Matched from indexed company URL: Coloplast Corp.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
21250502125050COLOPLAST MANUFACTURING US, LLC1Y2026-01-011601 W River Rd N MINNEAPOLIS MN US 55411
96107113002807917COLOPLAST MANUFACTURING FRANCE, SAS1N2026-01-019 Avenue Edmond Rostand CS 70218 Sarlat la Caneda Cedex Dordogne FR 24206
30113070483011307048Coloplast A/S - Mordrup Site1N2026-01-01Aa. Louis-Hansens Alle 15 Espergaerde Hovedstaden DK 3060
30300876933030087693Coloplast Manufacturing US, LLC.1Y2026-01-014008 Heritage Drive Brookshire TX US 77423
30329065743032906574Coloplast Manufacturing US LLC1N2026-01-01680 E Travelers Trl Ste 800 Burnsville MN US 55337
21253372125337COLOPLAST MANUFACTURING US LLC1N2020-04-251940 Commerce Dr North Mankato MN US 56003
30100524683010052468Coloplast Manufacturing US, LLC1N2020-04-254495 E Wall St Ontario CA US 91761
30121650361046831Coloplast Manufacturing US, LLC1Y2020-04-25475 Riverside Parkway Suite 400 Lithia Spgs GA US 30122

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
03600040963876Coloplast - AC5904+1(800)258-3476urology@coloplast.com
03600040963944Coloplast - AC5905+1(800)258-3476urology@coloplast.com
03600040964026Coloplast - AC5906+1(800)258-3476urology@coloplast.com
03600040964095Coloplast - AC5907+1(800)258-3476urology@coloplast.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
90771369373420P020003COLOPLAST SALINE-FILLED TESTICULAR PROSTHESISFAF2002-07-19
90771012210062P000006TITAN INFLATABLE PENILE PROSTHESISFHW2000-07-14
90801525424507K991202MODIFICATION TO WOUN'DRESMGQ1999-06-04
1879401525424507K991202MODIFICATION TO WOUN'DRESMGQ1999-06-04
1527231789041692K973070CONVEEN EASICATH SETEZD1997-11-06
1879401789041692K973070CONVEEN EASICATH SETEZD1997-11-06
90771356609227K944415ORIGIN TACKER SYSTEMOCW1994-11-28
90771931827456K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)PAH2024-10-18
90811099144368K242173Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)FED2024-11-12
90771332292165K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitOTM2023-09-25
3231821881526356K223821Self-Cath Closed SystemFCM2023-08-02
90771952048927K221874Altis Single Incision Sling SystemPAH2023-02-15
90771906284026K220420Saffron Fixation SystemPBQ2022-06-10
90771401773523K213186NovoFlow Reinforced Ureteral StentFAD2022-02-16
90811401773523K213186NovoFlow Reinforced Ureteral StentFAD2022-02-16
90771339843288K213185ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kitsFAD2022-06-08
90811339843288K213185ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kitsFAD2022-06-08
90811180206725K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsLJE2022-03-10
3231821180206725K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsLJE2022-03-10
90771874553927K201436Vortek Single Loop Ureteral StentFAD2021-02-25
90811874553927K201436Vortek Single Loop Ureteral StentFAD2021-02-25
1527231232889649K191536Biatain Silicone AgFRO2020-02-21
1879401232889649K191536Biatain Silicone AgFRO2020-02-21
1879401250002741K190620SpeediCath Flex Coude ProGBM2019-07-10
90772025273319K182831SabreLine and SabreGuard Laser FibersGEX2018-12-10
1879402025273319K182831SabreLine and SabreGuard Laser FibersGEX2018-12-10
90771982444827K182122Ureteric CathetersEYB2018-10-04
90811982444827K182122Ureteric CathetersEYB2018-10-04
1879401982444827K182122Ureteric CathetersEYB2018-10-04
90771276052437K181811ReTrace Ureteral Access SheathFED2018-09-07
90811276052437K181811ReTrace Ureteral Access SheathFED2018-09-07
1879401276052437K181811ReTrace Ureteral Access SheathFED2018-09-07
90771662130889K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral StentFAD2018-11-06
90811662130889K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral StentFAD2018-11-06
1879401662130889K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral StentFAD2018-11-06
1527231857604852K180258SpeediCath StandardGBM2018-10-25
1759491857604852K180258SpeediCath StandardGBM2018-10-25
1879401857604852K180258SpeediCath StandardGBM2018-10-25
90771146467756K180057VORTEK URETERAL DOUBLE LOOP STENTFAD2018-03-09
90811146467756K180057VORTEK URETERAL DOUBLE LOOP STENTFAD2018-03-09
1879401146467756K180057VORTEK URETERAL DOUBLE LOOP STENTFAD2018-03-09
90771773453675K173527Digitex Delivery DevicePWI2018-02-12
90772049026728K173501Meridian Vaginal Positioning System (VPS)PWK2018-02-09
3325422049026728K173501Meridian Vaginal Positioning System (VPS)PWK2018-02-09
90771134205747K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersEYB2017-12-21
90811134205747K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersEYB2017-12-21
1879401134205747K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersEYB2017-12-21
90811163059821K170531Ureteral Dilators and Percutaneous Nephrostomy DilatorsEZN2017-08-17
90772039312171K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTSFAD2017-11-02
90812039312171K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTSFAD2017-11-02
90771487418130K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTSFAD2017-11-15
90811487418130K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTSFAD2017-11-15
90771217803664K160766Ambu USR, Ambu MFAJ2016-08-17
1879401217803664K160766Ambu USR, Ambu MFAJ2016-08-17
90771399957817K150927Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiffOCY2015-05-27
90811399957817K150927Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiffOCY2015-05-27
1879401399957817K150927Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiffOCY2015-05-27
1759491836703167K143182Speedicath Compact MaleGBM2015-01-20
90811328865869K140523RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CMFED2014-07-24
90771188674193K140116RESTORELLE Y CONTOUR MESHOTO2014-02-12
90771417177546K132061RESTORELLE M, RESTORELLE XLOTO2013-08-02
90771504864868K123914RESTORELLE Y CONTOUROTO2013-03-05
90811400239377K123675RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, URFED2013-03-01
90771882664840K122968NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015OTO2012-12-18
90771741036400K122440RESTORELLE LOTO2012-11-19
1527231100181905K121833OSTOMY IRRIGATION SETEXD2012-07-16
1879401100181905K121833OSTOMY IRRIGATION SETEXD2012-07-16
3231821100181905K121833OSTOMY IRRIGATION SETEXD2012-07-16
90771230167469K121562ALTIS SINGLE INCISION CLING SYSTEMPAH2012-11-05
1527231498251775K121458SPEEDICATH COMPACT SET (12/18 FR)GBM2012-10-01
1759491498251775K121458SPEEDICATH COMPACT SET (12/18 FR)GBM2012-10-01
1879401498251775K121458SPEEDICATH COMPACT SET (12/18 FR)GBM2012-10-01
1527231780931743K121457SPEEDICATH COMPACT SET (12 FR)GBM2012-10-02
1879401780931743K121457SPEEDICATH COMPACT SET (12 FR)GBM2012-10-02
1879402009461569K120828BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHESFRO2012-04-05
90771346648272K120284DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEXNEW2012-05-23
90771512188655K113496VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KITOTM2012-02-14
1879401273308554K112860PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETERKNT2012-06-08
90771831478680K112386EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMOTP2011-09-08
90772061261249K112322RESTORELLE POLYPROPYLENE Y MESHOTO2012-05-17
90772070942186K111881VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KITOTM2011-08-17
90771821785839K111233SUPRIS RETROPUBIC SLING SYSTEMOTN2011-06-24
90771904089808K103568RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESHFTL2010-12-22
90771412980253K101297VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020OTM2010-06-03
1527231917523549K100878SELF CATH CATHETEREZD2010-05-26
1879401917523549K100878SELF CATH CATHETEREZD2010-05-26
1879401399213710K100218BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMFRO2010-02-17
90771316719289K093112DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGEGAW2010-02-01
90771095115586K091900ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICEGDW2009-07-16
90771020708125K090217BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070FBK2009-04-23
90811020708125K090217BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070FBK2009-04-23
1527232041781369K082831AMSELF CLOSED CATHETERIZATION SYSTEMFCM2008-10-23
1879402041781369K082831AMSELF CLOSED CATHETERIZATION SYSTEMFCM2008-10-23
1527231098151627K072808SPEEDICATH COMPACTGBM2007-11-09
1879401098151627K072808SPEEDICATH COMPACTGBM2007-11-09
1527231804783612K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMFCM2007-06-01
1879401804783612K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMFCM2007-06-01
1527231089171433K061615INTERDRY TEXTILE WITH SILVERFRL2006-12-22
1879401089171433K061615INTERDRY TEXTILE WITH SILVERFRL2006-12-22
1527232021220251K052229COLOPLAST OSTOMY ROD, MODEL 12814EZP2006-10-13
1879402021220251K052229COLOPLAST OSTOMY ROD, MODEL 12814EZP2006-10-13
90772007081193K050148MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KITOTN2005-03-09
1879401606593199K041316ANTIMICROBIAL ALGINATE DRESSINGFRO2004-08-05
90771119003808K040959MENTOR GENESIS PENILE PROSTHESISFAE2004-10-29
1527231923071866K023254SPEEDICATHGBM2003-01-27
1759491923071866K023254SPEEDICATHGBM2003-01-27
1879401923071866K023254SPEEDICATHGBM2003-01-27
90811014143884K013921PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2XFAD2002-10-17
1879401014143884K013921PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2XFAD2002-10-17
90811173916940K013174PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,EZL2002-01-04
1527231173916940K013174PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,EZL2002-01-04

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
FAD212022-06-08
GBM152019-07-10
EZL102002-01-04
FED82024-11-12
EYB72018-10-04
OTO62014-02-12
FCM52023-08-02
FRO52020-02-21
OTM42023-09-25
OCY42015-05-27
EZD42010-05-26
PAH32024-10-18
EXD32012-07-16
FBK32009-04-23
LJE22022-03-10
GEX22018-12-10
PWK22018-02-09
FAJ22016-08-17
OTN22011-06-24
FRL22006-12-22
EZP22006-10-13
MGQ21999-06-04
PBQ12022-06-10
PWI12018-02-12
EZN12017-08-17
KNT12012-06-08
NEW12012-05-23
OTP12011-09-08
FTL12010-12-22
GAW12010-02-01
GDW12009-07-16
FAE12004-10-29
FAF12002-07-19
FHW12000-07-14
OCW11994-11-28

NDC

PMA

Titan Inflatable Penile Prosthesis (IPP)

2023-01-12

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 Reas...

Titan Inflatable Penile Prosthesis (IPP)

2022-12-01

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 Reas...

Coloplast Saline-Filled Testicular Prosthesis (Torosa)

2022-09-16

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 Reas...

Coloplast Saline-Filled Testicular Prosthesis (Torosa)

2022-08-24

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 Reas...

Titan Inflatable Penile Prosthesis (IPP)

2022-08-24

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 Reas...

Titan Inflatable Penile Prosthesis (IPP)

2022-04-15

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 Reas...

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PMN

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GUDID

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