Signum Surgical Limited
IrelandFDA applicant, unverified FDA FEI 3015615781
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Signum Surgical Limited makes
Signum Surgical Limited manufactures the BioHealx Anal Fistula Device, a coil-based system designed for the closure of anal fistulas. The device is intended for use in surgical procedures to promote healing by sealing the fistula tract.
The BioHealx Anal Fistula Device is classified as a Class II medical device in the US. It is listed under the FDA’s 510(k) and UDI (Unique Device Identification) registries.
Catalogue
- Registry: GUDID
BioHealx Anal Fistula Device Ref DEN240007
Regimes: De Novo Registry: De Novo
Company details
- FDA FEI number
- 3015615781
- DUNS number
- 985655045
- Address
- Signum Surgical Limited, Galway Galway(City)
- [email protected]
- Phone
- 6108606577
Frequently asked questions
How many devices does Signum Surgical Limited have in the registry?
The registry currently lists 2 devices for Signum Surgical Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Signum Surgical Limited's devices?
Among its 2 most recently registered devices, Signum Surgical Limited has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Signum Surgical Limited's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Signum Surgical Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Signum Surgical Limited in the registry?
The most recently registered devices listed for Signum Surgical Limited include BioHealx Anal Fistula Device BH201X1 and BioHealx Anal Fistula Device.