Unident AB
Active in EUDAMEDSwedenfrom SRN EUDAMED SRN SE-MF-000004887
- Devices
- 67
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Unident AB makes
Unident AB manufactures dental sensor holders designed for intraoral imaging, including horizontal and vertical bitewing holders, periapical holders, and specialized variants like SnapBite and tab holders. These devices are engineered to secure digital sensors in fixed positions for dental X-rays, with variations in size, color, and orientation to accommodate different patient anatomies and imaging needs. The portfolio includes both standard and customizable holders for anterior, posterior, and apical views, ensuring compatibility with various dental imaging systems.
The company’s dental sensor holders are classified under EU Medical Device Regulations as Class I and Class IIa devices, reflecting their intended use and risk profiles. These products are registered in the EU’s eudamed database, a centralized repository for medical device information under the EU’s regulatory framework. Unident AB is based in Sweden, adhering to European Union medical device compliance requirements.
Catalogue
Search and filter all 67 devicesShowing 1-50 of 67
Company details
- EUDAMED SRN
- SE-MF-000004887
- EU VAT number
- SE556281809501
- EUDAMED status
- Active
- EUDAMED registered name
- Unident AB
- Registered address
- 2, Västerhavsvägen, 311 77, Falkenberg, Sweden
- Website
- www.unident.se
- facebook.com/unidentsverige
- [email protected]
- Phone
- +46 346 73 24 39
- PRRC contact
- Stina Gustafsson
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 16 Dec 2027
Intertek Medical Notified Body AB 2862 1 certificate
- 28620145488 Active
Quality management system EU MDR
- Issued
- 23 Mar 2023
- Expires
- 16 Dec 2027
From the company website
We offer everything from the få fö use materials and equipment for service and education. Smooth inköp and hög quality!
Frequently asked questions
How many devices does Unident AB have in the registry?
The registry currently lists 67 devices for Unident AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unident AB's devices?
Among its 50 most recently registered devices, Unident AB has devices listed in EUDAMED (50 devices).
What risk classes do Unident AB's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Unident AB's devices are Class I. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Unident AB?
EUDAMED lists 1 certificate for Unident AB (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 23 Mar 2023.
What are the newest devices from Unident AB in the registry?
The most recently registered devices listed for Unident AB include Unident sensor holder, Start kit size 1. Intraoral sensor holders for Schick 33, Vatech Ez and Sirona Xios., Unident sensor holder, Horizontal apical, size 2, Unident sensor holder, Horizontal bitewing tab, size 2 and Unident sensor holder, Posterior periapical holder size 2.