Sectra AB
Active in EUDAMEDSwedenfrom SRN EUDAMED FDA SRN SE-MF-000008882 FEI 3001104292
Sectra AB is a medical device manufacturer based in Sweden, with 68 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa and I) as of 12 Nov 2026.
- Devices
- 68
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 54
- EUDAMED 26
- FDA 510(k) 5
- Device classes
- FDA Class II 56
- EU Class IIa 8
- EU Class I 3
- FDA Class I 1
- Top EMDN categories
- Identifiers
- EUDAMED SRN SE-MF-000008882
- FDA FEI 3001104292
- DUNS 354117848
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
Catalogue
Search and filter all 68 devicesShowing 1-50 of 68
Company details
- EUDAMED SRN
- SE-MF-000008882
- FDA FEI number
- 3001104292
- DUNS number
- 354117848
- EU VAT number
- 556064830401
- EUDAMED status
- Active
- EUDAMED registered name
- Sectra AB
- EUDAMED abbreviated name
- Sectra AB
- Registered address
- 20, Teknikringen, 58330, Linkoping, Sweden
- Website
- www.sectra.com
- Phone
- +46 13 235200
- PRRC contact
- Madeleine Enström
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 9 Jul 2028
DNV Product Assurance AS 2460 1 certificate
- C622484 Active
Quality management system EU MDR
- Issued
- 10 Jul 2023
- Expires
- 9 Jul 2028
Frequently asked questions
How many devices does Sectra AB have in the registry?
The registry currently lists 68 devices for Sectra AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sectra AB's devices?
Among its 50 most recently registered devices, Sectra AB has devices listed in EUDAMED (22 devices) and FDA GUDID (41 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sectra AB's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Sectra AB's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Sectra AB?
EUDAMED lists 1 certificate for Sectra AB (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 10 Jul 2023.
What are the newest devices from Sectra AB in the registry?
The most recently registered devices listed for Sectra AB include Sectra Core 28.2, Sectra Core 28.1, Sectra Core 26.2 and Sectra Core 27.2.