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Ultimate rTMS M-100 Ultimate

by Shenzhen Yingzhi Technology Co., Ltd.

Ref 02-020-01Model M-100 Ultimate

Ultimate rTMS M-100 Ultimate is a device classified as Class IIa in the EU and Class II in the US made by Shenzhen Yingzhi Technology Co., Ltd., registered in EUDAMED on 7 Aug 2026 (Basic UDI-DI B-06971538580019), cleared under FDA 510(k) K230735 on 13 Sep 2023 and listed in FDA GUDID since 16 Jan 2024 (UDI-DI 06971538580019), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230735

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06971538580019 Basic UDI-DI 06971538580019UDI-DIDate7 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971538580019 UDI-DI Date16 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230735 Date13 Sep 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06971538580019 registered 7 Aug 2026 Active
  • FDA 510(k) K230735 decided 13 Sep 2023 Active
  • FDA GUDID UDI-DI 06971538580019 listed 16 Jan 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K230735
  2. Listed FDA GUDID 06971538580019
  3. Registered EUDAMED B-06971538580019

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Pulsed Magnetic Stimulation Device EUDAMED
Ultimate rTMS GUDID
Generic name
Magnetic neural stimulation system
Model / reference
M-100 Ultimate, 02-020-01
Primary DI / UDI-DI
06971538580019
Basic UDI-DI
B-06971538580019
510(k) Number
FDA product code
OBP
EMDN code
Z120606 Magnetotherapy equipment
GMDN term
Magnetic neural stimulation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.5805
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Magnetic neural stimulation system

Cleared under the same submission (K230735)

and 8 more cleared under K230735

Similar devices in this category

Other devices filed under MAGNETOTHERAPY EQUIPMENT.

Other devices from Shenzhen Yingzhi Technology Co., Ltd.

See all devices from Shenzhen Yingzhi Technology Co., Ltd. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)