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Coloplast A/S

Denmark·DK-MF-000025526

Last updated September 17, 2026

What Coloplast A/S makes

Coloplast A/S manufactures ostomy products including one-piece and multiple-piece intestinal ostomy bags (both open-ended and closed-ended), convex intestinal ostomy base plates, and urological devices such as single-use surgical procedure kits, polymeric ureteral stents, single-administration urethral drainage catheters, and indwelling urethral drainage balloon catheters (non-antimicrobial).

The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, and Class III, and are listed in the EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in Denmark.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Denmark
Address: 1, Holtedam, Humlebaek, Denmark
Website: www.coloplast.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +4549111111
PRRC Contact: —
EUDAMED SRN: DK-MF-000025526
FDA FEI Number: 3002806731
DUNS Number: 305524696

Catalogue (5549)

Page 105 of 111

Device	Model / Reference	Registries	Class	Status
Assura	141020	EUDAMED	Class I	Active
SenSura Mio Convex	16523	EUDAMED	Class I	Active
SenSura Mio Convex	16312	EUDAMED	Class I	Active
SenSura Flex	14921	EUDAMED	Class I	Active
Assura	12140	EUDAMED	Class I	Active
SenSura Flex	10112	EUDAMED	Class I	Active
SenSura Mio	186000	EUDAMED	Class I	Active
Assura	14196	EUDAMED	Class I	Active
SenSura Flex	11316	EUDAMED	Class I	Active
SenSura	11804	EUDAMED	Class I	Active
Assura	1758	EUDAMED	Class I	Active
Assura	2135	EUDAMED	Class I	Active
SenSura Mio Convex	18675	EUDAMED	Class I	Active
SenSura	118010	EUDAMED	Class I	Active
Alterna	13840	EUDAMED	Class I	Active
Assura	2745	EUDAMED	Class I	Active
Assura	12155	EUDAMED	Class I	Active
Assura	12375	EUDAMED	Class I	Active
Assura	2115	EUDAMED	Class I	Active
Alterna Free	46339	EUDAMED	Class I	Active
SenSura Mio Convex	19559	EUDAMEDFDA UDI	Class I	Active
Alterna	14163	EUDAMED	Class I	Active
Self-Cath	50452	EUDAMED	Class I	Active
Assura	138500	EUDAMED	Class I	Active
SenSura	153140	EUDAMED	Class I	Active
SenSura Mio	197880	EUDAMED	Class I	Active
SenSura Mio Kids	187220	EUDAMED	Class I	Active
Alterna	13986	EUDAMED	Class I	Active
SenSura Mio	10564	EUDAMED	Class I	Active
SenSura Mio Convex	186750	EUDAMED	Class I	Active
Assura	121740	EUDAMED	Class I	Active
Assura	13954	EUDAMED	Class I	Active
SenSura Convex Xpro	11275	EUDAMED	Class I	Active
SenSura Mio Convex	16955	EUDAMED	Class I	Active
SenSura Flex	13224	EUDAMED	Class I	Active
Assura	12845	EUDAMED	Class I	Active
SenSura Mio	186210	EUDAMED	Class I	Active
SenSura Flex	10915	EUDAMED	Class I	Active
Assura	12994	EUDAMED	Class I	Active
SenSura Mio	10571	EUDAMED	Class I	Active
SenSura	17540	EUDAMED	Class I	Active
Assura	14106	EUDAMED	Class I	Active
Self-Cath	50455	EUDAMEDFDA UDI	Class I	Active
Alterna	5575	EUDAMED	Class I	Active
Assura	2883	EUDAMEDFDA UDI	Class I	Active
SenSura Flex	11821	EUDAMED	Class I	Active
SenSura Convex	11277	EUDAMED	Class I	Active
Assura	14297	EUDAMEDFDA UDI	Class I	Active
Alterna	2832	EUDAMED	Class I	Active
Alterna	17634	EUDAMED	Class I	Active

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