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 has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIb | 91 |
|---|
Most frequent device types declared: BIP Foley Catheter - Silicone, BIP Foley Catheter - Latex, BIP Foley Tiemann Tip.
Among these devices, 91 are declared sterile.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | BACTIGUARD (South East Asia) Sdn. Bhd. (MY) · FDA 3005315793 |
| Devices in EUDAMED | 91 |
| Country of registration | Sweden |
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2253382CE02 | issued | 2028-01-01 |
2253382CE01 | issued | 2028-01-01 |