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Belt

by BTL Industries Limited

Ref 699-BELT-M

Belt is a magnetic neural stimulation system (EU MDR Class I; FDA Class II; FDA product code OBP, Transcranial Magnetic Stimulator) made by BTL Industries Limited, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI ++B108699ACCEUW7) and listed in FDA GUDID since 6 Nov 2024 (UDI-DI B108699BELTMEU00), active as of 12 Nov 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++B108699ACCEUW7 Basic UDI-DI B108699BELTMEU00UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB108699BELTMEU00 UDI-DI Date6 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++B108699ACCEUW7 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI B108699BELTMEU00 listed 6 Nov 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID B108699BELTMEU00
  2. Registered EUDAMED ++B108699ACCEUW7

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  • Withdrawn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

Generic name
Magnetic neural stimulation system
Device name
EXOMIND accessories
Model / reference
699-BELT-M EUDAMED
Belt GUDID
Primary DI / UDI-DI
B108699BELTMEU00
Basic UDI-DI
++B108699ACCEUW7
FDA product code
OBP
EMDN code
Z12011299 Patient positioning instruments – other
GMDN term
Magnetic neural stimulation system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5805
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
699-BELT-M
GUDID
Belt
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS – OTHER.

Other devices from BTL Industries Limited

See all devices from BTL Industries Limited →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)