Skip to content

Deep TMS system 104 with H1

by BrainsWay Ltd.

Ref SYS-104-001Model Model 104

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011053DeepTMS3X Basic UDI-DI 07290110538026UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290110538026 UDI-DI Date14 Mar 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Deep TMS system 104 with H1 EUDAMED
Deep Transcranial Magnetic Stimulation (DTMS) System GUDID
Generic Name
Magnetic neural stimulation system
Device Name
Deep TMS System Model 104
Model / Ref / Catalog
Model 104, SYS-104-001, 104
Primary DI / UDI-DI
07290110538026
Basic UDI-DI
729011053DeepTMS3X
Direct Marketing DI
07290110538026
510(k) Number
FDA Product Code
OBP
EMDN Code
Z12101105 Magnetic stimulators
GMDN Term
Magnetic neural stimulation system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
882.5805
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Weight — 161 Kilogram
Height — 205 Centimeter
Length — 68 Centimeter
Width — 68.8 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Model 104
SYS-104-001
GUDID
104
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
IL-MF-000029177
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Brainsway, Ltd.

See all devices from Brainsway, Ltd. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No