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Sign in to claim this brandAerin Medical Inc.
United States·US-MF-000048272
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 2565, Leghorn St., Mountain View, United States
- Website
- www.aerinmedical.com
- —
- —
- [email protected]
- Phone
- +1 833‑484‑8237
- PRRC Contact
- Teri Feeley
- EUDAMED SRN
- US-MF-000048272
- FDA FEI Number
- 3011625895
- DUNS Number
- 051512253
Catalogue (28)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| InSeca ARC Stylus | FG256 | FDA UDI | Class II | Active |
| Sterile Aquasonic 100 Ultrasound Transmission Gel | MS303 | FDA UDI | Class II | Active |
| Power Cord | CAT309-02 | FDA UDI | Class II | Active |
| VivAer® Stylus | FG1787 | FDA UDI | Class II | Active |
| VivAer® Stylus | FG722 | FDA UDI | Class II | Active |
| Aerin Console Set | FG2045 | FDA UDI | Class II | Active |
| RhinAer® Stylus | FG1393 | FDA UDI | Class II | Active |
| Power Cord (OUS) 15 FT | MS1222 | FDA UDI | Class II | Active |
| RhinAer+ Stylus | FG2258 | FDA UDI | Class II | Active |
| Reach Needle | CAT1614-05 | FDA UDI | Class II | Active |
| Power Cord (OUS) | MS589 | FDA UDI | Class II | Active |
| RhinAer Stylus | FG815 | FDA UDI | Class II | Active |
| Aerin Console | FG2045 | FDA UDI | Class II | Active |
| Power Cord (UK) | MS588 | FDA UDI | Class II | Active |
| Foot Switch | CAT307 | FDA UDI | Class II | Active |
| Power Cord (UK) 15 FT | MS1223 | FDA UDI | Class II | Active |
| Aerin Console Set | CAT305 | FDA UDI | Class II | Active |
| Aerin Console | FG226 | FDA UDI | Class II | Active |
| Power Cord 15 ft (US) | MS1198 | FDA UDI | Class II | Active |
| VivAer Stylus | K200300 | FDA 510(k) | Class II | Active |
| Aerin Medical Wand Model FG011 | K150637 | FDA 510(k) | Class II | Active |
| Vivaer ARC Stylus | K172529 | FDA 510(k)FDA UDI | Class II | Active |
| Reach Needle | K240253 | FDA 510(k) | Class II | Active |
| RHIN1 Stylus | K192471 | FDA 510(k) | Class II | Active |
| InSeca ARC Stylus, Aerin Console | K162810 | FDA 510(k) | Class II | Active |
| RhinAer® Stylus (FG1393) | K221907 | FDA 510(k) | Class II | Active |
| Aerin Console | CAT305-03 | EUDAMED | Class IIb | Active |
| RhinAer Stylus | CAT1395 | EUDAMED | Class IIb | Active |
Related Companies
Authorised Representatives
- Obelis s.a. BE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 12, 2024 | Z-0808-2025 | — | open, classified | Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console. |