Unident AB
Active in EUDAMEDSwedenfrom SRN EUDAMED SRN SE-MF-000004887
- Devices
- 67
- Registrations
- EUDAMED
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
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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!