Rfsu
Active in EUDAMEDSwedenfrom SRN EUDAMED SRN SE-MF-000008574
- Devices
- 87
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Rfsu makes
The company manufactures latex condoms under various brand names, including Birds'N Bees, Mamba, Okiedo, Profil, and Kilroy.
These products are classified as Class II medical devices and are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Search and filter all 87 devicesShowing 1-50 of 87
Company details
- EUDAMED SRN
- SE-MF-000008574
- EU VAT number
- 556039-2986
- EUDAMED status
- Active
- EUDAMED registered name
- RFSU AB
- EUDAMED abbreviated name
- Susanne Vesterinen
- Registered address
- 21, Löjtnantsgatan, 115 50, Stockholm, Sweden
- Website
- www.rfsu.com
- [email protected]
- PRRC contact
- Susanne Vesterinen
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 8 Mar 2027
Intertek Medical Notified Body AB 2862 1 certificate
- 28620129092-01 Expiring
Quality management system EU MDR
- Issued
- 11 Mar 2026
- Expires
- 8 Mar 2027
Frequently asked questions
How many devices does Rfsu have in the registry?
The registry currently lists 87 devices for Rfsu. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rfsu's devices?
Among its 50 most recently registered devices, Rfsu has devices listed in EUDAMED (45 devices) and FDA 510(k) (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Rfsu's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Rfsu's devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Rfsu?
EUDAMED lists 1 certificate for Rfsu (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 11 Mar 2026.
What are the newest devices from Rfsu in the registry?
The most recently registered devices listed for Rfsu include RFSU Profil, Tunto Kookas XL, RFSU Grande XL and RFSU Mix Pack.