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MagPro Accessories Flow Arm

by Tonica Elektronik A/S

Ref 9016B0801

MagPro Accessories Flow Arm (9016B0801) 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 6 Nov 2026 (Basic UDI-DI 5713484FlowArm2T), cleared under FDA 510(k) K193006 on 9 Aug 2020 (1 earlier submission) and listed in FDA GUDID since 25 Nov 2022 (UDI-DI 05713484031235), 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 linked in EUDAMED

A group certificate may exist

510(k) K193006

+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 Number5713484FlowArm2T Basic UDI-DI 05713484031235UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05713484031235 UDI-DI Date25 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193006 Date9 Aug 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5713484FlowArm2T registered 6 Nov 2026 Active
  • FDA 510(k) K193006 decided 9 Aug 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05713484031235 listed 25 Nov 2022 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K061645
  2. Cleared FDA 510(k) K193006
  3. Listed FDA GUDID 05713484031235
  4. Registered EUDAMED 5713484FlowArm2T

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  • Withdrawn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
Flow Arm (incl. 2 x coil clamps, ø38) EUDAMED
MagPro Accessories GUDID
Generic name
Magnetic neural stimulation system
Device name
Flow Arm
Model / Ref / Catalog
9016B0801, Flow Arm
Primary DI / UDI-DI
05713484031235
Basic UDI-DI
5713484FlowArm2T
Direct marketing DI
05713484031235
510(k) Number
FDA product code
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
882.5802, 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
9016B0801
GUDID
Flow Arm
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 (K061645)

and 8 more cleared under K061645

Cleared under the same submission (K193006)

and 4 more cleared under K193006

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)