# Bluewind Medical Ltd. (specification developer, Herzliya Central, IL): 1 new FDA device listing, incl. implanted tibial electrical urinary continence device

**Score:** 60/100

| Field | Value |
|---|---|
| Establishment | Bluewind Medical Ltd. |
| Owner / operator | BlueWind Medical Ltd. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Herzliya Central, IL |
| New listings | 1 |
| Devices | Implanted Tibial Electrical Urinary Continence Device |
| Product codes | QXM |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology |
| Brand names | Revi System; Revi Extend Implant |
| First new listing | 2026-08-04 |
| Latest new listing | 2026-08-04 |
| FDA registration number | 3012239564 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.