Transcutan AB
Active in EUDAMEDSwedenfrom SRN EUDAMED SRN SE-MF-000015798
- Devices
- 5
- Registrations
- EUDAMED
At a glance
EU certificates
3 of 3 in force.
Market reach
- European Union
- EUDAMED actor, 3 certificates
Catalogue
T-port Replacement Kit with Luer Ref 1020-1/L
Regimes: CE MDR Registry: EUDAMEDT-port Enteral Implant Kit with Luer Ref 1010-1/L
Regimes: CE MDR Registry: EUDAMEDT-port Enteral Implant Kit with ENFit Ref 1010-1/E
Regimes: CE MDR Registry: EUDAMEDT-port Enteral Replacement Kit with ENFit Ref 1020-1/E
Regimes: CE MDR Registry: EUDAMEDT-port Enteral Tools Kit Ref 1030-1
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- SE-MF-000015798
- EU VAT number
- SE-556602838601
- EUDAMED status
- Active
- EUDAMED registered name
- Transcutan AB
- Registered address
- 4, Lilla Torget, SE-411 18, Göteborg, Sweden
- Website
- www.transcutan.com
- linkedin.com/company/transcutan
- [email protected]
- Phone
- +46766318951
- PRRC contact
- Niklas Hofverberg
EUDAMED certificates
3 certificates3 valid, 0 expiredMDR 3next expiry 19 Jan 2027
TÜV Rheinland LGA Products GmbH 0197 3 certificates
- IZ 2285527-1 Expiring
Technical documentation EU MDR
- Issued
- 11 Jul 2025
- Expires
- 20 Sep 2027
- Reason
- Mnf data change
- IZ 2285527-2 Expiring
Technical documentation EU MDR
- Issued
- 11 Jul 2025
- Expires
- 20 Sep 2027
- Reason
- Mnf data change
- HZ 2285527-1 Expiring
Quality management system EU MDR
- Issued
- 11 Jul 2025
- Expires
- 19 Jan 2027
- Reason
- Mnf data change
From the company website
Transcutan is a Swedish Medtech company that develops the next generation of access technology. Solutions that help patients live a better and simpler life.
Frequently asked questions
How many devices does Transcutan AB have in the registry?
The registry currently lists 5 devices for Transcutan AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Transcutan AB's devices?
Among its 5 most recently registered devices, Transcutan AB has devices listed in EUDAMED (5 devices).
What risk classes do Transcutan AB's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Transcutan AB's devices are Class I and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Transcutan AB?
EUDAMED lists 3 certificates for Transcutan AB (technical documentation; quality management system) under MDR. The most recent was issued on 11 Jul 2025.
What are the newest devices from Transcutan AB in the registry?
The most recently registered devices listed for Transcutan AB include T-port Replacement Kit with Luer, T-port Enteral Implant Kit with Luer, T-port Enteral Implant Kit with ENFit and T-port Enteral Replacement Kit with ENFit.