Abena A/S
DK-MF-000002482 · Denmark · Aabenraa
Abena A/S is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 41 |
|---|
Devices declared under this manufacturer
- ABENA San Premium
- Bambo Nature Pants 5
- Bambo Nature Pants 6
- Examination Nitrile Gloves, powder free
- Examination gloves, ABENA Classic
- Examination gloves, ABENA Classic COATS
- Examination gloves, ABENA Excellent Accelerator free
- Nitril Food PRO, powder free blue gloves Wirfly L
- Nitril Food PRO, powder free blue gloves Wirfly M
- Nitril Food PRO, powder free blue gloves Wirfly S
- Nitril Food PRO, powder free blue gloves Wirfly XL
- Nitril Food PRO, powder free blue gloves Wirfly XS
Showing 12 of 41 declared devices.
Catalogue references include 1000019258, 1000021301, 1000028954, 1000032572, 1010001920, 1999902088.
European nomenclature codes declared: T01020204, T04010102, T0205.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 41 |
| Country of registration | Denmark |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 41 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 14.6 % |
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ABENA A/S |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2025-10-16 |
Licence types: Device Family (1).
Licensed under: ABENA CLASSIC NITRILE POWDER FREE MEDICAL EXAM.
North American profile: Canada only. Abena A/S holds a Canadian licence but was not found in the U.S. register.