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MagPro Accessories Flex Arm-Long

by Tonica Elektronik A/S

Ref 9016B0171

MagPro Accessories Flex Arm-Long (9016B0171) is a device classified as Class I in the EU and Class II in the US made by Tonica Elektronik A/S, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 5713484FlexArmXH), cleared under FDA 510(k) K160280 on 16 May 2016 (1 earlier submission) and listed in FDA GUDID since 25 Nov 2022 (UDI-DI 05713484030054), active as of 7 Nov 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K160280

+1 more

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 05713484030054UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05713484030054 UDI-DI Date25 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160280 Date16 May 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5713484FlexArmXH registered 9 Oct 2026 Active
  • FDA 510(k) K160280 decided 16 May 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05713484030054 listed 25 Nov 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

4 dated events

  1. Cleared FDA 510(k) K150641
  2. Cleared FDA 510(k) K160280
  3. Listed FDA GUDID 05713484030054
  4. Registered EUDAMED 5713484FlexArmXH

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Super Flex Arm for Coils (long) EUDAMED
MagPro Accessories GUDID
Generic name
Magnetic neural stimulation system
Device name
Flex Arm
Model / Ref / Catalog
9016B0171, Flex Arm-Long
Primary DI / UDI-DI
05713484030054
Basic UDI-DI
5713484FlexArmXH
Direct marketing DI
05713484030054
510(k) Number
FDA product code
OBP, 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
882.5805, 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
9016B0171
GUDID
Flex Arm-Long
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

Cleared under the same submission (K150641)

and 8 more cleared under K150641

Cleared under the same submission (K160280)

and 8 more cleared under K160280

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

  • Single use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)