Coloplast A/S
DK-MF-000025526 · Denmark · Humlebaek
Coloplast A/S is registered in the European database on medical devices as a manufacturer, with 11 480 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 11 412 |
|---|---|
| Class IIb | 68 |
Among these devices, 697 are declared sterile.
Devices declared under this manufacturer
- Alterna
- Assura
- Conveen
- Conveen Contour
- Conveen Security+
- EasiCath
- SenSura
- SenSura Click
- SenSura Flex
- SenSura Mio
- SenSura Mio Concave
- SenSura Mio Convex
Showing 12 of 11 480 declared devices.
Catalogue references include 053800, 119510, 14217, 14896, 149050, 157600.
European nomenclature codes declared: A10020202,A10020302, A1002010402, A1001010102,A1001020102, A1002010401, A10020402, A1001030202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | COLOPLAST A/S (DK) · FDA 9610694 |
| Devices in EUDAMED | 11 480 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 11 480 |
|---|---|
| Found in the U.S. device database | 31 |
| Share | 0.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | COLOPLAST A/S |
What it holds in Canada
| Licences on record | 39 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 35 |
| Class 3 devices | 4 |
| First licensed | 1999-06-17 |
Licence types: Device Family (28), Single Device (7), Device Group Family (2), Device Group (1).
Licensed under: GENESIS MALLEABLE PENILE PROSTHESIS, BONEE, BIATAIN ALGINATE AG, PERISTEEN PLUS TRANSANAL IRRIGATION, VIRTUE MALE SLING SYSTEM, PERISTEEN TRANSANAL IRRIGATION TUBE.
North American profile: Both markets. Coloplast A/S is registered in both the United States and Canada.