Directa AB
Active in EUDAMEDSwedenfrom SRN EUDAMED FDA SRN SE-MF-000002500 FEI 3004586882
- Devices
- 945
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
What Directa AB makes
Directa AB manufactures reusable and single-use dental instruments, including x-ray film holders, moulds, temporary crowns, abrasive strips, endodontic files, periotomes, and wedges. Their portfolio also includes dentifrice and preformed dental crowns designed for temporary use. The company produces manual dental tools for procedures like endodontics and crown preparation, alongside consumables for dental imaging and restorative work.
The company’s devices are classified under Class I and Class II regulations, with products listed in the FDA’s Unique Device Identifier (UDI) database. Directa AB is based in Sweden and adheres to relevant European and global regulatory standards for dental instruments and consumables.
Catalogue
Search and filter all 945 devicesShowing 1-50 of 945
Company details
- EUDAMED SRN
- SE-MF-000002500
- SRN (system / procedure pack)
- SE-PR-000027622
- FDA FEI number
- 3004586882
- DUNS number
- 353954381
- EU VAT number
- SE556013882701
- EUDAMED status
- Active
- EUDAMED registered name
- Directa AB
- Registered address
- 8, Finvids väg, 19447, Upplands Väsby, Sweden
- Website
- www.directadental.com
- Phone
- +46703565090
- PRRC contact
- Tomas Skeppmark
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 26 Dec 2027
Intertek Medical Notified Body AB 2862 2 certificates
- 28620139228 Active
Quality management system EU MDR
- Issued
- 9 Jan 2023
- Expires
- 27 Dec 2027
- 28620239917 Active
Quality management system EU MDR
- Issued
- 9 Mar 2026
- Expires
- 26 Dec 2027
Frequently asked questions
How many devices does Directa AB have in the registry?
The registry currently lists 945 devices for Directa AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Directa AB's devices?
Among its 50 most recently registered devices, Directa AB has devices listed in EUDAMED (1 device) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Directa AB's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Directa AB's devices are Class I. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Directa AB?
EUDAMED lists 2 certificates for Directa AB (quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 9 Mar 2026.
What are the newest devices from Directa AB in the registry?
The most recently registered devices listed for Directa AB include TrollByte Kimera Endo 4104/3104, ContacEZ Restorative, TrollByte Kimera Endo 2907/2907 and Directa Temporary Polycarbonate Crowns 50.