Loop Diagnostics S.L.
Active in EUDAMEDSpainfrom SRN EUDAMED SRN ES-MF-000047379
- Devices
- 3
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
SEPTILOOP - LoopStrip Ref SL002
Regimes: CE IVDR Registry: EUDAMEDSeptiLoop Ref SL001
Regimes: CE IVDR Registry: EUDAMEDLoopReagent Ref SL001R
Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- ES-MF-000047379
- EU VAT number
- B67326322
- EUDAMED status
- Active
- EUDAMED registered name
- Loop Diagnostics S.L.
- EUDAMED abbreviated name
- LoopDx
- Registered address
- 31, Street ROC BORONAT, 08005, Barcelona, Spain
- Website
- loopdx.com/
- linkedin.com/company/loopdx
- [email protected]
- PRRC contact
- Eduard Guerrero Aiguabella
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 24 Jul 2030
TÜV SÜD Product Service GmbH 0123 1 certificate
- V76 121228 0001 Active
Technical documentation EU IVDR
- Issued
- 22 Sep 2026
- Expires
- 24 Jul 2030
- Reason
- Add device or group
From the company website
Loop Diagnostics is a biotech company that develops a diagnostic tool for sepsis, using an in vitro cellular immunoassay to detect it within the first hour of bloodstream infection. Their goal is to reduce disease severity and mortality rates through timely and effective treatment.
Frequently asked questions
How many devices does Loop Diagnostics S.L. have in the registry?
The registry currently lists 3 devices for Loop Diagnostics S.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Loop Diagnostics S.L.'s devices?
Among its 3 most recently registered devices, Loop Diagnostics S.L. has devices listed in EUDAMED (3 devices).
What risk classes do Loop Diagnostics S.L.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Loop Diagnostics S.L.'s devices are IVDR Class A and IVDR Class C. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Loop Diagnostics S.L.?
EUDAMED lists 1 certificate for Loop Diagnostics S.L. (technical documentation) under IVDR. The most recent was issued on 22 Sep 2026.
What are the newest devices from Loop Diagnostics S.L. in the registry?
The most recently registered devices listed for Loop Diagnostics S.L. include SEPTILOOP - LoopStrip, SeptiLoop and LoopReagent.