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Coloplast Corp.

Last updated May 30, 2026

Information

Country: US
Address: —
Website: coloplast.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)258-3476
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 847436391

Catalogue (77)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Manhood	27-4200-B / 50710	FDA UDI	Class I	Active
InterDry	7915	FDA UDI	Class I	Active
InterDry	7910	FDA UDI	Class I	Active
InterDry	7912	FDA UDI	Class I	Active
Insertion Tool	NTER01	FDA UDI	Class I	Active
Nouvelle (tm) Model #901, Sizes 0-12, Left & Right	K904316	FDA 510(k)	Class I	Active
Vortek Ureteral Double Loop Stent	K180057	FDA 510(k)	Class II	Active
Exair Anterior And Posterior Prolapse Repair System	K112386	FDA 510(k)	Class III	Active
Comfeel Seasorb Dressing	K983519	FDA 510(k)	Class I	Active
Biatain 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)	K231953	FDA 510(k)	U	Active
SpeediCath Flex Set	K222059	FDA 510(k)	Class II	Active
Restorelle L	K122440	FDA 510(k)	Class II	Active
SpeediCath Compact Set	K192904	FDA 510(k)	Class II	Active
Amoena Breast Forms	K853822	FDA 510(k)	Class I	Active
Conveen Easicath Set	K973070	FDA 510(k)	Class II	Active
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)	K242173	FDA 510(k)	Class II	Active
Ureteral Dilators and Percutaneous Nephrostomy Dilators	K170531	FDA 510(k)	Class II	Active
Personally(tm), Model 241 Sizes 0-12, Left & Right	K864786	FDA 510(k)	Class I	Active
Amoena Affinity Model #802	K915382	FDA 510(k)	Class I	Active
Luja Coudé	K251116	FDA 510(k)	Class II	Active
Speedicath	K023254	FDA 510(k)	Class II	Active
Luja Coude	K241210	FDA 510(k)	Class II	Active
Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 Cm X 10cm), 9613 (6x6 (15cm X 15cm)	K013525	FDA 510(k)	U	Active
In-Ka Ureteral Balloon Dilatation Catheter	K201007	FDA 510(k)	Class II	Active
SureCath Set	K242049	FDA 510(k)	Class II	Active
SabreLine and SabreGuard Laser Fibers	K182831	FDA 510(k)	Class II	Active
Self-Cath Closed System	K223821	FDA 510(k)	Class II	Active
Luja Set	K250270	FDA 510(k)	Class II	Active
Biatain Foam Adhesive Dressing	K983173	FDA 510(k)	U	Active
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath	K201165	FDA 510(k)	U	Active
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)	K203637	FDA 510(k)	Class II	Active
Compeed Psoriasis Dressing	K982493	FDA 510(k)	U	Active
Comfeel Purilon Gel, 15g(3900)/Comfeel Purilon Gel, 25g(3903)	K971597	FDA 510(k)	Class I	Active
SpeedCath Compact Male	K210250	FDA 510(k)	Class II	Active
Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015	K122968	FDA 510(k)	Class II	Active
Folysil Silicone Catheter	K233411	FDA 510(k)	Class II	Active
Restorelle M, Restorelle Xl	K132061	FDA 510(k)	Class II	Active
SpeediCath Soft	K200142	FDA 510(k)	Class II	Active
Speedicath Compact	K072808	FDA 510(k)	Class II	Active
Luja Coude (20108 Male CH18 - large packaging)	K233101	FDA 510(k)	Class II	Active
SpeediCath Standard	K180258	FDA 510(k)	Class II	Active
Vortek Single Loop Ureteral Stent	K201436	FDA 510(k)	Class II	Active
Coloplast Ostomy Rod, Model 12814	K052229	FDA 510(k)	Class II	Active
Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)	K241028	FDA 510(k)	Class II	Active
Contreet Foam Adhesive/Non-Adhesive	K022416	FDA 510(k)	U	Active
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit	K231891	FDA 510(k)	Class II	Active
Skin Support Prep Pad	K923351	FDA 510(k)	Class I	Active
Contreet Foam Cavity Dressing With Silver, Model 9628 (2x4 In.)	K033869	FDA 510(k)	U	Active
SpeediCath Flex Coude	K161672	FDA 510(k)	Class II	Active
SpeediCath Flex Coude Pro	K190620	FDA 510(k)	Class II	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 12, 2007	Z-0715-2008	—	terminated	Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.
Nov 12, 2007	Z-0713-2008	—	terminated	Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.
Nov 12, 2007	Z-0714-2008	—	terminated	Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.