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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 18 of 111| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alterna | 15874 | FDA UDI | Class I | Active |
| Vortek | BCFD67 | FDA UDI | Class II | Active |
| Assura | 12385 | FDA UDI | Class I | Active |
| Vortek | ACA108 | FDA UDI | Class II | Active |
| Porges Coloplast | RBB010 | FDA UDI | Class II | Active |
| SenSura Mio Convex | 13733 | FDA UDI | Class I | Active |
| SpeediCath Standard | 28485 | FDA UDI | Class II | Active |
| Porges Coloplast | BCFA64 | FDA UDI | Class II | Active |
| SureCath | 28005 | FDA UDI | Class II | Active |
| Assura | 12136 | FDA UDI | Class I | Active |
| Assura | 12577 | FDA UDI | Class I | Active |
| Porges Coloplast | AJ4C62 | FDA UDI | Class II | Active |
| Porges Coloplast | AA6C24 | FDA UDI | Class II | Active |
| Porges Coloplast | BNAA63 | FDA UDI | Class II | Active |
| SpeediCath Flex Coude | 28920 | FDA UDI | Class II | Unknown |
| Assura | 1759 | FDA UDI | Class I | Active |
| Biosoft | BCAF86 | FDA UDI | Class II | Active |
| SenSura Mio Convex | 16730 | FDA UDI | Class I | Active |
| SenSura Mio | 10502 | FDA UDI | Class I | Active |
| Kolibri | RJB006 | FDA UDI | U | Active |
| Porges Coloplast | AXXL12 | FDA UDI | Class II | Unknown |
| SenSura Click | 10167 | FDA UDI | Class I | Active |
| Titan | ENR914 | FDA UDI | Class III | Active |
| SenSura | 15534 | FDA UDI | Class I | Active |
| Porges Coloplast | BCAS85 | FDA UDI | Class II | Active |
| Assura | 13625 | FDA UDI | Class I | Active |
| Biatain Silicone Ag | 39638 | FDA UDI | U | Active |
| Peristeen | 29125 | FDA UDI | Class II | Active |
| SenSura Mio Convex | 16740 | FDA UDI | Class I | Active |
| ImaJin | AJ4Y86 | FDA UDI | Class II | Active |
| Vortek | ACBM57 | FDA UDI | Class II | Active |
| SenSura Mio Kids | 18710 | FDA UDI | Class I | Active |
| Porges Coloplast | BNAA73 | FDA UDI | Class II | Active |
| Sensura Flex | 11591 | FDA UDI | Class I | Active |
| SenSura Click | 11841 | FDA UDI | Class I | Active |
| ImaJin | AJ4765 | FDA UDI | Class II | Active |
| Porges Coloplast | AA6122 | FDA UDI | Class II | Active |
| Assura | 14451 | FDA UDI | Class I | Active |
| Comfeel Plus | 33120 | FDA UDI | Class I | Active |
| SenSura Mio | 11474 | FDA UDI | Class I | Active |
| SenSura Mio Convex | 16335 | FDA UDI | Class I | Active |
| Coloplast | AE0E38 | FDA UDI | Class II | Active |
| Assura | 12384 | FDA UDI | Class I | Active |
| Porges Coloplast | ACBS46 | FDA UDI | Class II | Active |
| Porges Coloplast | ACB175 | FDA UDI | Class II | Active |
| ImaJin | AJ4885 | FDA UDI | Class II | Active |
| Self-Cath | 50463 / 214 | FDA UDI | Class II | Active |
| Assura | 12175 | FDA UDI | Class I | Active |
| Kolibri | RCJ112 | FDA UDI | U | Active |
| SenSura Mio Convex | 18676 | FDA UDI | Class I | Active |
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