Synthon Hispania S.L.
Active in EUDAMEDSpainfrom SRN EUDAMED FDA SRN ES-MF-000004771 FEI 3004837462
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Synthon Hispania S.L. makes
Synthon Hispania S.L. manufactures medical devices including GripMate, Sensigo, Autoxon, and Myject.
These devices are classified as Class II and Class IIa and are listed in the Eudamed and FDA 510(k) registries. The company is based in Spain.
Catalogue
GripMate Ref K243232
510(k) 510(k)- CE MDR EUDAMED
- CE MDR EUDAMED
- CE MDR EUDAMED
- CE MDR EUDAMED
Company details
- EUDAMED SRN
- ES-MF-000004771
- FDA FEI number
- 3004837462
- EU VAT number
- ESB61739645
- EUDAMED status
- Active
- EUDAMED registered name
- Synthon Hispania S.L.
- Registered address
- 1, Castello, 08830, Sant Boi de Llobregat, Spain
- [email protected]
- PRRC contact
- Ana Romero
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 23 Nov 2028
Notified body 2797 1 certificate
- MDR 771470 Issued
Quality assurance EU MDR
- Issued
- 24 Nov 2023
- Expires
- 23 Nov 2028
Frequently asked questions
How many devices does Synthon Hispania S.L. have in the registry?
The registry currently lists 5 devices for Synthon Hispania S.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Synthon Hispania S.L.'s devices?
Among its 5 most recently registered devices, Synthon Hispania S.L. has devices listed in EUDAMED (4 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Synthon Hispania S.L.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Synthon Hispania S.L.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Synthon Hispania S.L.?
EUDAMED lists 1 certificate for Synthon Hispania S.L. (quality assurance) under MDR. 1 is recorded with the status issued. The most recent was issued on 2023-11-24.
What are the newest devices from Synthon Hispania S.L. in the registry?
The most recently registered devices listed for Synthon Hispania S.L. include GripMate, Sensigo, Myject and Autoxon.