Coloplast A/S - Mordrup Site

Matched from indexed company URL: Coloplast A

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3011307048	3011307048	Coloplast A/S - Mordrup Site	1	N	2026-01-01	Aa. Louis-Hansens Alle 15 Espergaerde Hovedstaden DK 3060

GUDID Contact Samples

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

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

coloplast.com

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
175949	1857604852	K180258	SpeediCath Standard	GBM	2018-10-25
175949	1836703167	K143182	Speedicath Compact Male	GBM	2015-01-20
175949	1498251775	K121458	SPEEDICATH COMPACT SET (12/18 FR)	GBM	2012-10-01
175949	1923071866	K023254	SPEEDICATH	GBM	2003-01-27
175949	1398980614
175949	1471863104
175949	1554983951

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
GBM	4	2018-10-25

PMN

Altis Single Incision Sling System

2023-02-15

Coloplast A/S

Saffron Fixation System

2022-06-10

Coloplast A/S

Biatain Silicone Ag

2020-02-21

Coloplast A/S

ReTrace Ureteral Access Sheath

2018-09-07

Coloplast A/S

Digitex Delivery Device

2018-02-12

Coloplast A/S

Peristeen Anal Irrigation System

2015-09-03

COLOPLAST A/S

SpeediCath Compact Eve

2015-07-02

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

COLOPLAST A/S

Speedicath Compact Male

2015-01-20

COLOPLAST A/S

RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM

2014-07-24

COLOPLAST A/S

RESTORELLE Y CONTOUR MESH

2014-02-12

COLOPLAST A/S

ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC

2013-07-09

COLOPLAST A/S

RESTORELLE Y CONTOUR

2013-03-05

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

COLOPLAST A/S

ALTIS SINGLE INCISION CLING SYSTEM

2012-11-05

COLOPLAST A/S

SPEEDICATH COMPACT SET (12/18 FR)

2012-10-01

COLOPLAST A/S

OSTOMY IRRIGATION SET

2012-07-16

COLOPLAST A/S

PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER

2012-06-08

COLOPLAST A/S

DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX

2012-05-23

COLOPLAST A/S

RESTORELLE POLYPROPYLENE Y MESH

2012-05-17

COLOPLAST A/S

BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES

2012-04-05

COLOPLAST A/S

VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT

2012-02-14

COLOPLAST A/S

VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT

2011-08-17

COLOPLAST A/S

SUPRIS RETROPUBIC SLING SYSTEM

2011-06-24

COLOPLAST A/S

PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE

2011-01-31

COLOPLAST A/S

RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH

2010-12-22

COLOPLAST A/S

RE-TRACE URETERAL ACCESS SHEATH

2010-10-18

COLOPLAST A/S

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020

2010-06-03

COLOPLAST A/S

BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM

2010-02-17

COLOPLAST A/S

COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM

2009-11-23

COLOPLAST A/S

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS

2009-05-08

COLOPLAST A/S

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020

2009-05-07

COLOPLAST A/S

BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070

2009-04-23

COLOPLAST A/S

COMFEEL:ALGINATE DRESSING

1995-09-29

COLOPLAST A/S

CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER

1995-02-13

COLOPLAST A/S

COMFEEL(R) WOUND DRESSING SD

1993-03-16

COLOPLAST A/S

CONVEEN(R) LEG BAG(500 ML)

1992-10-30

COLOPLAST A/S

CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH

1992-09-23

COLOPLAST A/S

COMFEEL WOUND DRESSING ORD

1992-08-17

COLOPLAST A/S

COMFEEL WOUND DRESSING SD

1992-08-17

COLOPLAST A/S

71 records. Showing 1-40. Next

GUDID

SpeediCath Flex Set - 28941

Coloplast A/S

2026-02-05

SpeediCath Flex Set - 28942

Coloplast A/S

2026-02-05

SpeediCath Flex Set - 28946

Coloplast A/S

2026-02-05

Coloplast - AC5904

Coloplast A/S

2026-01-30

Coloplast - AC5905

Coloplast A/S

2026-01-30

Coloplast - AC5906

Coloplast A/S

2026-01-30

Coloplast - AC5907

Coloplast A/S

2026-01-30

Coloplast - AC5908

Coloplast A/S

2026-01-30

Coloplast - AC5909

Coloplast A/S

2026-01-30

Coloplast - AC5910

Coloplast A/S

2026-01-30

Coloplast - AC5911

Coloplast A/S

2026-01-30

Coloplast - AC5912

Coloplast A/S

2026-01-30

Coloplast - AC5C07

Coloplast A/S

2026-01-30

Coloplast - ACP205

Coloplast A/S

2026-01-30

Coloplast - ACP206

Coloplast A/S

2026-01-30

Coloplast - ACP207

Coloplast A/S

2026-01-30

Coloplast - ACP208

Coloplast A/S

2026-01-30

Coloplast - ACP303

Coloplast A/S

2026-01-30

Coloplast - ACP304

Coloplast A/S

2026-01-30

Coloplast - ACP305

Coloplast A/S

2026-01-30

Coloplast - ACP306

Coloplast A/S

2026-01-30

Coloplast - ACP307

Coloplast A/S

2026-01-30

Coloplast - ACP403

Coloplast A/S

2026-01-30

Coloplast - ACP404

Coloplast A/S

2026-01-30

Coloplast - ACP405

Coloplast A/S

2026-01-30

Coloplast - ACP406

Coloplast A/S

2026-01-30

Coloplast - ACP407

Coloplast A/S

2026-01-30

Coloplast - ACP603

Coloplast A/S

2026-01-30

Coloplast - ACP604

Coloplast A/S

2026-01-30

Coloplast - ACP605

Coloplast A/S

2026-01-30

Coloplast - ACP606

Coloplast A/S

2026-01-30

Coloplast - ACP607

Coloplast A/S

2026-01-30

Coloplast - ACR205

Coloplast A/S

2026-01-30

Coloplast - ACR206

Coloplast A/S

2026-01-30

Coloplast - ACR207

Coloplast A/S

2026-01-30

SenSura Mio - 114910

Coloplast A/S

2026-01-21

SenSura Mio - 114920

Coloplast A/S

2026-01-21

SenSura Mio - 114970

Coloplast A/S

2026-01-21

SenSura Mio - 114980

Coloplast A/S

2026-01-21

SenSura Mio - 114990

Coloplast A/S

2026-01-21

200 records. Showing 1-40. Next