Proverum, Ltd.
IrelandFDA applicant, unverified FDA FEI 3038132878
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Proverum, Ltd. makes
Proverum, Ltd. manufactures the ProVee System, a medical device designed for the treatment of benign prostatic hyperplasia (BPH). This system is intended for transurethral procedures to address urinary obstruction caused by an enlarged prostate.
The ProVee System is classified as a Class III device under FDA regulations and is authorised through a Premarket Approval (PMA) application. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
ProVee Video Processing Unit (PV-003) Ref K251734
Regimes: 510(k) Registry: 510(k)ProVee System for BPH Ref P250011
Regimes: PMA Registry: PMA
Company details
- FDA FEI number
- 3038132878
- Address
- Unit 3, Galway Galway(County)
FDA establishments
- Proverum Limited DUBLIN 1 Dublin(County) · IE FEI 3017896224
Frequently asked questions
How many devices does Proverum, Ltd. have in the registry?
The registry currently lists 4 devices for Proverum, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Proverum, Ltd.'s devices?
Among its 4 most recently registered devices, Proverum, Ltd. has devices listed in FDA 510(k) (1 device), FDA PMA (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Proverum, Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Proverum, Ltd.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Proverum, Ltd. in the registry?
The most recently registered devices listed for Proverum, Ltd. include ProVee System for BPH PV-002, ProVee Video Processing Unit PV-003, ProVee Video Processing Unit (PV-003) and ProVee System for BPH.
Which FDA establishments are linked to Proverum, Ltd.?
1 FDA establishment is linked to Proverum, Ltd. in the registry; they are listed on the company page.