Bactiguard AB
SE-MF-000020790 · Sweden · Tullinge
Bactiguard AB is registered in the European database on medical devices as a manufacturer, with 91 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 91 |
|---|
Most frequent device types declared: BIP Foley Catheter - Latex, BIP Foley Catheter - Silicone, BIP Foley Tiemann Tip.
Among these devices, 91 are declared sterile.
Devices declared under this manufacturer
- BIP Foley Catheter - Silicone, 2-way 12 Fr 10cc
- BIP Foley Catheter - Silicone, 2-way 16 Fr 10cc
- BIP Foley Catheter - Silicone, 2-way 22 Fr 10cc
- BIP Foley Catheter - Silicone, 2-way 24 Fr 30cc
- BIP Foley Catheter - Silicone, 2-way 26 Fr 10cc
- BIP Foley Catheter - Silicone, 3-way 16 Fr 10cc
- BIP Foley Catheter - Silicone, 3-way 18 Fr 10cc
- BIP Foley Catheter - Silicone, 3-way 20 Fr 30cc
- BIP Foley Catheter - Silicone, 3-way 22 Fr 30cc
- BIP Foley Catheter - Silicone, 3-way 24 Fr 30cc
- BIP Foley Catheter - Silicone, 3-way 26 Fr 10cc
- BIP Foley Catheter 3-way, 16 Ch/Fr, 30ml/cc
Showing 12 of 91 declared devices.
Catalogue references include 112163010, 115221020, 115243010, 115261010, 116203020, 116223020.
European nomenclature codes declared: U010299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 91 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 91 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BACTIGUARD AB |
North American profile: Canada only. Bactiguard AB holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2253382CE02 | issued | 2028-01-01 |
2253382CE01 | issued | 2028-01-01 |