Bluewind Medical Ltd.
Active in EUDAMEDIsraelfrom SRN EUDAMED FDA SRN IL-MF-000009870 FEI 3012239564
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
- Authorised rep.
- AR Experts B.V.NL
Catalogue
Revi System Ref K253651
RENOVA iStim™ OAB2000 Ref MA-1007-0600
Revi System Ref K252391
Revi System Ref DEN220073
Revi™ System Ref K240037
Company details
- EUDAMED SRN
- IL-MF-000009870
- FDA FEI number
- 3012239564
- EUDAMED status
- Active
- EUDAMED registered name
- BlueWind Medical Ltd
- EUDAMED abbreviated name
- BWM
- Registered address
- 4, Maskit Street, 4614002, Herzliya, Israel
- [email protected]
- PRRC contact
- Angel Estrada
FDA establishments
- Bluewind Medical, Inc. Salt Lake City, UT · US FEI 3038988751
What Bluewind Medical Ltd. makes
BlueWind Medical Ltd. manufactures the Renova iStim™ OAB2000, a device designed for the treatment of overactive bladder (OAB) symptoms through neuromodulation therapy.
The company’s portfolio is classified under Active Implantable Medical Device Directives (AIMDD) and is registered in the EU’s eudamed database. The company is based in Israel.
Frequently asked questions
How many devices does BLUEWIND MEDICAL LTD. have in the registry?
The registry currently lists 5 devices for BLUEWIND MEDICAL LTD.. Devices recorded under merged duplicate company entries are counted once.
Which registries list BLUEWIND MEDICAL LTD.'s devices?
Among its 5 most recently registered devices, BLUEWIND MEDICAL LTD. has devices listed in EUDAMED (1 device) and FDA 510(k) (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do BLUEWIND MEDICAL LTD.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for BLUEWIND MEDICAL LTD.'s devices are Class II and active implantable (AIMDD). Each device page shows its own class and authorisation.
What are the newest devices from BLUEWIND MEDICAL LTD. in the registry?
The most recently registered devices listed for BLUEWIND MEDICAL LTD. include Revi System, RENOVA iStim™ OAB2000 and Revi™ System.
Which FDA establishments are linked to BLUEWIND MEDICAL LTD.?
1 FDA establishment is linked to BLUEWIND MEDICAL LTD. in the registry; they are listed on the company page.