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MagPro Accessories Flex Arm-Short

by Tonica Elektronik A/S

Ref 9016B0181

MagPro Accessories Flex Arm-Short (9016B0181) is a magnetic neural stimulation system (EU MDR Class I; FDA Class II) made by Tonica Elektronik A/S, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 5713484FlexArmXH) and listed in FDA GUDID since 25 Nov 2022 (UDI-DI 05713484030061), active as of 7 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5713484FlexArmXH Basic UDI-DI 05713484030061UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05713484030061 UDI-DI Date25 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5713484FlexArmXH registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI 05713484030061 listed 25 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05713484030061
  2. Registered EUDAMED 5713484FlexArmXH

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  • Withdrawn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
Super Flex Arm for Coils (short) EUDAMED
MagPro Accessories GUDID
Generic name
Magnetic neural stimulation system
Device name
Flex Arm
Model / Ref / Catalog
9016B0181, Flex Arm-Short
Primary DI / UDI-DI
05713484030061
Basic UDI-DI
5713484FlexArmXH
Direct marketing DI
05713484030061
FDA product code
QPL, OBP, QCI, GWF
EMDN code
Z12101180 Peripheral or central neuro stimulation and assessment instruments - hardware accessories
GMDN term
Magnetic neural stimulation system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5890, 882.5805, 882.5802, 882.1870
EU registration type
Standard device
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
9016B0181
GUDID
Flex Arm-Short
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 PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS.

Other devices from Tonica Elektronik A/S

See all devices from Tonica Elektronik A/S →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)