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Data / Medical devices / Denmark / Coloplast A/S

Coloplast A/S: FDA-registered device maker in HUMLEBAEK Hovedstaden, Denmark, 21 510(k) clearances

Coloplast A/S is registered with the FDA (registration 9610694) in HUMLEBAEK Hovedstaden, Denmark. It lists 22 device types. The FDA files 21 510(k) clearances under its listings, the newest dated July 7, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Coloplast A/S
FDA registration number
9610694
FEI number
3002806731
Address
Holtedam 1, HUMLEBAEK Hovedstaden, Denmark, DK-3050
Owner or operator
Coloplast Corp. (8010144)
Roles
Contract manufacturer, Specification developer
First device listed
November 2, 1995
Registered through
2027
Brand names listed
Assura 1pc Kit, Assura CV Kit, Assura Irrigation Pressplate, Assura Irrigation Set, Assura Kit, Assura Night bag, Assura Ostomy Pouch, Assura Urostomy Pouch and more

Devices it lists

DeviceProduct codeClassRoleSource
Bag, Drainage, With Adhesive, OstomyFON1Specification developeraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-SterileNNW1Specification developeraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Specification developeraccessdata.fda.gov
Bandage, Liquid, Skin ProtectantNEC1Specification developeraccessdata.fda.gov
Catheter, Continuous IrrigationGBQ1Specification developeraccessdata.fda.gov
Catheter, StraightEZD2Specification developeraccessdata.fda.gov
Catheter, UrethralGBM2Specification developeraccessdata.fda.gov
Collector, OstomyEXB1Specification developeraccessdata.fda.gov
Device, Incontinence, Urosheath Type, Non-SterileNNX1Specification developeraccessdata.fda.gov
Dressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicMGQUSpecification developeraccessdata.fda.gov
Dressing, Wound, DrugFROUSpecification developeraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Specification developeraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Contract manufacturer, Specification developeraccessdata.fda.gov
Enema KitFCE1Specification developeraccessdata.fda.gov
Irrigator, OstomyEXD2Specification developeraccessdata.fda.gov
Ostomy Care KitPQE1Specification developeraccessdata.fda.gov
Rod, ColostomyEZP2Specification developeraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Specification developeraccessdata.fda.gov
Solvent, Adhesive TapeKOX1Specification developeraccessdata.fda.gov
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)FCM2Specification developeraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 7, 2026K262045Luja SoftEZDSubstantially EquivalentColoplast A.S.accessdata.fda.gov
June 27, 2025K251116Luja CoudéEZDSubstantially EquivalentColoplast Corp.accessdata.fda.gov
April 17, 2025K250270Luja SetEZDSubstantially EquivalentColoplast Corp.accessdata.fda.gov
November 26, 2024K242049SureCath SetEZDSubstantially EquivalentColoplast Corp.accessdata.fda.gov
July 26, 2024K241028Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZDSubstantially EquivalentColoplastaccessdata.fda.gov
March 22, 2024K231953Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)FROSubstantially EquivalentColoplast Corp.accessdata.fda.gov
August 2, 2023K223821Self-Cath Closed SystemFCMSubstantially EquivalentColoplastaccessdata.fda.gov
December 2, 2022K221401Self-Cath and Self-Cath PlusEZDSubstantially EquivalentColoplastaccessdata.fda.gov
September 21, 2022K222059SpeediCath Flex SetEZDSubstantially EquivalentColoplastaccessdata.fda.gov
April 26, 2022K210250SpeedCath Compact MaleEZDSubstantially EquivalentColoplastaccessdata.fda.gov
March 8, 2022K203637SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)EZDSubstantially EquivalentColoplastaccessdata.fda.gov
November 13, 2020K200820SpeediCath Compact SetGBMSubstantially EquivalentColoplastaccessdata.fda.gov
November 2, 2020K192904SpeediCath Compact SetGBMSubstantially EquivalentColoplastaccessdata.fda.gov
July 30, 2020K200142SpeediCath SoftGBMSubstantially EquivalentColoplastaccessdata.fda.gov
February 21, 2020K191536Biatain Silicone AgFROSubstantially EquivalentColoplast A/Saccessdata.fda.gov
July 10, 2019K190620SpeediCath Flex Coude ProGBMSubstantially EquivalentColoplastaccessdata.fda.gov
October 25, 2018K180258SpeediCath StandardGBMSubstantially EquivalentColoplastaccessdata.fda.gov
September 3, 2015K140310Peristeen Anal Irrigation SystemKNTSubstantially EquivalentColoplast A/Saccessdata.fda.gov
July 16, 2012K121833OSTOMY IRRIGATION SETEXDSubstantially EquivalentColoplast A/Saccessdata.fda.gov
February 17, 2010K100218BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMFROSubstantially EquivalentColoplast A/Saccessdata.fda.gov
June 4, 1999K991202MODIFICATION TO WOUN'DRESMGQSubstantially EquivalentColoplast Corp.accessdata.fda.gov

Compare with other makers

Updated July 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.