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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 2 of 2

Device	Model / Reference	Registries	Class	Status
Amoena Breast Forms	K864785	FDA 510(k)	Class I	Active
SpeediCath Compact Set	K200820	FDA 510(k)	Class II	Active
Comfeel:alginate Filler	K954857	FDA 510(k)	Class I	Active
Speedicath Compact Set (12 Fr)	K121457	FDA 510(k)	Class II	Active
Meridian Vaginal Positioning System (VPS)	K173501	FDA 510(k)	Class II	Active
NovoFlow Reinforced Ureteral Stent	K213186	FDA 510(k)	Class II	Active
SpeediCath Flex Coude Pro	K180070	FDA 510(k)	Class II	Active
Biatain Foam Dressing	K983163	FDA 510(k)	U	Active
Heylo™ System	K252140	FDA 510(k)	Class I	Active
Ureteric Catheters	K182122	FDA 510(k)	Class II	Active
Conveen Urine Bag - Sterile	K955609	FDA 510(k)	Class I	Active
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets	K211911	FDA 510(k)	U	Active
Biosoft Duo Double Loop Ureteral Stents	K170422	FDA 510(k)	Class II	Active
Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)	K230165	FDA 510(k)	Class II	Active
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits	K213185	FDA 510(k)	Class II	Active
Self-Cath and Self-Cath Plus	K221401	FDA 510(k)	Class II	Active
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters	K171043	FDA 510(k)	Class II	Active
Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)	K242473	FDA 510(k)	Class II	Active
ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent	K180469	FDA 510(k)	Class II	Active
Suoena Affinity (tm) Model #802	K921535	FDA 510(k)	Class I	Active
Sween Woun'dres	K983042	FDA 510(k)	U	Active
Conveen Leg Bag Strap	K953783	FDA 510(k)	Class I	Active
Vortek Hydro-Coated Double Loop Ureteral Stents	K170362	FDA 510(k)	Class II	Active
Modification To Woun'dres	K991202	FDA 510(k)	U	Active
Mentor Polytef Paste For Injection	N16420	FDA PMA	Class III	Active
Mentor Saline-Filled Testicular Prosthesis	P020003	FDA PMA	Class III	Active
Titan Inflatable Penile Prosthesis	P000006	FDA PMA	Class III	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.