Bactiguard AB
Active in EUDAMEDSwedenfrom SRN EUDAMED SRN SE-MF-000020790
Bactiguard AB is a medical device manufacturer based in Sweden, with 81 devices listed in EUDAMED (EU Class IIb) as of 13 Nov 2026.
- Devices
- 81
- Registrations
- EUDAMED
Registry facts
- Registries
- EUDAMED 81
- Device classes
- EU Class IIb 81
- Top EMDN categories
- Identifiers
- EUDAMED SRN SE-MF-000020790
At a glance
EU certificates
0 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
What Bactiguard AB makes
Bactiguard AB manufactures silicone Foley catheters designed for urinary drainage, including standard 2-way and 3-way variants with varying French sizes and balloon capacities. The portfolio includes both regular and Tiemann-tip designs, catering to different patient needs in clinical settings. All products are intended for short- and long-term use in medical environments.
These devices fall under EU Class IIb classification and are registered in the EUDAMED database. The company is based in Sweden and adheres to regulatory requirements for medical devices within the European Union.
Catalogue
Search and filter all 81 devicesShowing 1-50 of 81
Company details
- EUDAMED SRN
- SE-MF-000020790
- EU VAT number
- SE556668662101
- EUDAMED status
- Active
- EUDAMED registered name
- Bactiguard AB
- EUDAMED abbreviated name
- BG
- Registered address
- 150, Alfred Nobels Allé, 146 48, Tullinge, Sweden
- Website
- www.bactiguard.com/
- info@bactiguard.com
- Phone
- +46 8 440 58 80
- PRRC contact
- Alf Laurell
EUDAMED certificates
2 certificates0 valid, 0 expired, 2 withdrawn or suspendedMDR 2
DEKRA Certification B.V. 0344 2 certificates
- 2253382CE01 Cancelled
Quality management system EU MDR
- Issued
- 9 Jan 2023
- Expires
- 1 Jan 2028
- Reason
- Other
- 2253382CE02 Cancelled
Quality management system EU MDR
- Issued
- 9 Feb 2024
- Expires
- 1 Jan 2028
- Reason
- Other
From the company website
Bactiguard is a global MedTech company developing safe and biocompatible technology to prevent medical device-related infections.
Frequently asked questions
How many devices does Bactiguard AB have in the registry?
The registry currently lists 81 devices for Bactiguard AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bactiguard AB's devices?
Among its 50 most recently registered devices, Bactiguard AB has devices listed in EUDAMED (50 devices).
What risk classes do Bactiguard AB's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Bactiguard AB's devices are Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Bactiguard AB?
EUDAMED lists 2 certificates for Bactiguard AB (quality management system) under MDR. The most recent was issued on 9 Feb 2024.
What are the newest devices from Bactiguard AB in the registry?
The most recently registered devices listed for Bactiguard AB include BIP Foley Catheter - Silicone, 2-way 26 Fr 30cc, BIP Foley Catheter 2-way, 24 Ch/Fr, 30ml/cc, BIP Foley Catheter - Silicone, 2-way 14 Fr 10cc and BIP Foley Catheter 2-way, 22 Ch/Fr, 10ml/cc.