Suturion AB
Active in EUDAMEDSwedenfrom SRN EUDAMED FDA SRN SE-MF-000033154 FEI 3038138322
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Suturion AB makes
Suturion AB manufactures surgical suturing devices, including the Suture-TOOL System and SutureTOOL, designed for precise tissue approximation and wound closure in operating room settings. These products are intended for use in general surgery, orthopedics, and other specialties requiring controlled suture placement.
The company’s devices are classified as Class II and Class IIa under EU regulations and are listed in the EUDAQS database (eudamed) and the FDA’s 510(k) premarket notification registry. Suturion AB is headquartered in Sweden.
Catalogue
- Registry: GUDID
- Registry: GUDID
Suture-TOOL System Ref K250977
Regimes: 510(k) Registry: 510(k)Suture-TOOL System Ref K242835
Regimes: CE MDR 510(k) Registry: 510(k)SutureTOOL Ref 1018S
Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- SE-MF-000033154
- FDA FEI number
- 3038138322
- DUNS number
- 353236163
- EU VAT number
- SE559148597301
- EUDAMED status
- Active
- EUDAMED registered name
- Suturion AB
- Registered address
- 1, Scheeleteorget, 22363, LUND, Sweden
- Website
- www.suturion.com/
- [email protected]
- Phone
- +46728663448
- PRRC contact
- Nils Myhr
Frequently asked questions
How many devices does Suturion AB have in the registry?
The registry currently lists 5 devices for Suturion AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suturion AB's devices?
Among its 5 most recently registered devices, Suturion AB has devices listed in EUDAMED (1 device), FDA 510(k) (2 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Suturion AB's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Suturion AB's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Suturion AB in the registry?
The most recently registered devices listed for Suturion AB include Suture USP 2-0, Suture USP 0, Suture-TOOL System and SutureTOOL.