Is this your brand? Sign in to claim ownership.
Sign in to claim this brandColoplast 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
- —
- —
- [email protected]
- Phone
- +4549111111
- PRRC Contact
- —
- EUDAMED SRN
- DK-MF-000025526
- FDA FEI Number
- 3002806731
- DUNS Number
- 305524696
Catalogue (5549)
Page 19 of 111| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SenSura | 15524 | FDA UDI | Class I | Active |
| ImaJin | AJ4A73 | FDA UDI | Class II | Active |
| Porges Coloplast | BCFD44 | FDA UDI | Class II | Active |
| SenSura Click | 11855 | FDA UDI | Class I | Active |
| SenSura Mio | 12296 | FDA UDI | Class I | Active |
| Porges Coloplast | AE0E38 | FDA UDI | Class II | Active |
| ImaJin | BCHJ76 | FDA UDI | Class II | Active |
| SenSura Mio Convex | 18989 | FDA UDI | Class I | Active |
| Porges Coloplast | BCAM75 | FDA UDI | Class II | Active |
| Self-Cath Plus | 50512 / 4612 | FDA UDI | Class II | Active |
| Porges Coloplast | BCFA65 | FDA UDI | Class II | Active |
| Biosoft | BCAF75 | FDA UDI | Class II | Active |
| Porges Coloplast | AB6724 | FDA UDI | Class II | Unknown |
| SenSura Mio Kids | 18720 | FDA UDI | Class I | Active |
| Porges Coloplast | BCHT84 | FDA UDI | Class II | Active |
| Porges Coloplast | ACB565 | FDA UDI | Class II | Active |
| SenSura Mio | 10476 | FDA UDI | Class I | Active |
| Folysil | AA6120 | FDA UDI | Class II | Active |
| Self-Cath | 50465 / 608 | FDA UDI | Class II | Active |
| Coloplast | AE0035 | FDA UDI | Class II | Active |
| Freedom Clear | 505431 | FDA UDI | Class I | Active |
| Assura | 14229 | FDA UDI | Class I | Active |
| Conveen Security+ | 05230 | FDA UDI | Class I | Active |
| SenSura Mio | 18680 | FDA UDI | Class I | Active |
| Porges Coloplast | BCAF75 | FDA UDI | Class II | Active |
| SenSura Mio Convex Flip | 18403 | EUDAMEDFDA UDI | Class I | Active |
| Porges Coloplast | AXXS10 | FDA UDI | Class II | Unknown |
| SenSura Mio | 13607 | FDA UDI | Class I | Active |
| Sensura Flex | 11306 | FDA UDI | Class I | Active |
| Porges Coloplast | ACB266 | FDA UDI | Class II | Active |
| Porges Coloplast | AJ4575 | FDA UDI | Class II | Unknown |
| SpeediCath Standard | 28486 | FDA UDI | Class II | Active |
| Porges Coloplast | AA6110 | FDA UDI | Class II | Active |
| Porges Coloplast | AJ4876 | FDA UDI | Class II | Unknown |
| Porges Coloplast | AA6422 | FDA UDI | Class II | Active |
| Porges Coloplast | ACBM65 | FDA UDI | Class II | Active |
| SenSura Mio Kids | 18735 | FDA UDI | Class I | Active |
| Restorelle | 501450 | FDA UDI | Class II | Active |
| SenSura | 15696 | FDA UDI | Class I | Active |
| Porges Coloplast | BCAS65 | FDA UDI | Class II | Active |
| Brava | 4247.0 | FDA UDI | Class I | Active |
| Vortek | BCFD76 | FDA UDI | Class II | Active |
| Porges Coloplast | BCAF77 | FDA UDI | Class II | Active |
| Porges Coloplast | ACB284 | FDA UDI | Class II | Active |
| Porges Coloplast | AA6324 | FDA UDI | Class II | Active |
| Assura | 12174 | FDA UDI | Class I | Active |
| ImaJin | AJ4C63 | FDA UDI | Class II | Active |
| ImaJin | AJ4863 | FDA UDI | Class II | Active |
| Biosoft | BCAF72 | FDA UDI | Class II | Active |
| Coloplast | 14010 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.