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MagPro X100 incl. MagOption

by Tonica Elektronik A/S

Ref 9016E0731

MagPro X100 incl. MagOption (9016E0731) is a magnetic neural stimulation system (EU MDD Class IIa; FDA Class II) made by Tonica Elektronik A/S, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-05713484010032) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05713484010032), active as of 7 Nov 2026.

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

CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05713484010032 Basic UDI-DI 05713484010032UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05713484010032 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05713484010032 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 05713484010032 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05713484010032
  2. Registered EUDAMED B-05713484010032

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
MagPro X100 incl. MagOption EUDAMED
MagPro GUDID
Generic name
Magnetic neural stimulation system
Model / Ref / Catalog
9016E0731, X100 incl. MagOption
Primary DI / UDI-DI
05713484010032
Basic UDI-DI
B-05713484010032
FDA product code
GWF, OBP, QPL
EMDN code
Z12101105 Magnetic stimulators
GMDN term
Magnetic neural stimulation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1870, 882.5805, 882.5890
EU registration type
Legacy device (under a directive)
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
9016E0731
GUDID
X100 incl. MagOption
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

Similar devices in this category

Other devices filed under MAGNETIC STIMULATORS.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)