This page includes the latest FDA filings for Brainsway L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3010300912 | ||||||||
| FEI Number | 3010300912 | ||||||||
| Name | BRAINSWAY LTD. | ||||||||
| Owner & Operator | Brainsway Ltd. | ||||||||
| Contact Address | 19 Hartom Str. Har Hahotzvim Jerusalem IL-JM Yerushalayim 91451 IL | ||||||||
| US Agent |
| ||||||||
| Importing Logistics Registration |
| ||||||||
| Registration Status | 1 | ||||||||
| Initial Importer | N | ||||||||
| Registration Expiration | 2020-04-25 | ||||||||
| Registration Address | 19 Hartom Str. Har Hahotzvim Jerusalem Yerushalayim, 91451 IL | ||||||||
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
BrainsWay Ltd. | BrainsWay Deep TMS System | 2022-08-26 |
Brainsway Ltd. | Brainsway Deep TMS System | 2021-04-23 |
Brainsway Ltd. | Brainsway Deep (DTMS) System | 2021-04-16 |
Brainsway Ltd. | Brainsway Deep TMS System | 2020-08-21 |
Brainsway Ltd. | Brainsway Deep TMS System | 2019-03-08 |
Brainsway Ltd. | Brainsway Deep (DTMS) System | 2018-05-03 |
| BRAINSWAY LTD | Power Supply Module - 115V | 2018-03-29 |
| BRAINSWAY LTD | Cart Module | 2018-03-29 |
| BRAINSWAY LTD | Cooling System - 24V | 2018-03-29 |
| BRAINSWAY LTD | Positioning Module 102B | 2018-03-29 |
| BRAINSWAY LTD | H1-Coil | 2018-03-29 |
BRAINSWAY LTD. | Brainsway Deep TMS System | 2013-06-24 |
BRAINSWAY, LTD | BRAINSWAY DEEP TMS SYSTEM | 2013-01-07 |
| NCAGE Code | 3841A | BRAINSWAY LTD. |
| CAGE Code | 3841A | BRAINSWAY LTD. |
| SEC | 0001505065 | Brainsway Ltd. of ISRAEL |
| SEC | 0001765764 | Brainsway Ltd./ADR |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020091050720 | Valencia,Spain -> Long Beach, California | 14 SKIDS OF DEEP TMS BASE SYSTEM (MEDICAL DEV ICE) IN VOICE NO : T2017 CUSTOM S CLEARANC E BY CORNELL DE LIVERY TO FINAL DESTINATIO N BY CARRIER SHIP TO: PRE FERRED DEPOT 14331 CHAMBER S RD TUSTIN, CA 92780 UNIT ED STATES ATTN: SETH ANDER SON TEL.: 8447702727 H.S.# 9 01890004 | 14 PKG |
| 2018042135761 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | 4 CASES OFEXHIBITION GOODS | 4 PKG |