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MagPro R20

by Tonica Elektronik A/S

Ref 9016E0861

MagPro R20 (9016E0861) is a device classified as Class IIa in the EU and Class II in the US made by Tonica Elektronik A/S, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-05713484010087), cleared under FDA 510(k) K160280 on 16 May 2016 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05713484010087), active as of 7 Nov 2026.

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

CE MDD 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) K160280

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05713484010087 Basic UDI-DI 05713484010087UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05713484010087 UDI-DI Date24 Sep 2016ListedStatusListed 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 B-05713484010087 registered 30 Oct 2026 Active
  • FDA 510(k) K160280 decided 16 May 2016 Active
  • FDA GUDID UDI-DI 05713484010087 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160280
  2. Listed FDA GUDID 05713484010087
  3. Registered EUDAMED B-05713484010087

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
MagPro R20 EUDAMED
MagPro GUDID
Generic name
Magnetic neural stimulation system
Model / Ref / Catalog
9016E0861, R20
Primary DI / UDI-DI
05713484010087
Basic UDI-DI
B-05713484010087
510(k) Number
FDA product code
GWF, OBP
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
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
9016E0861
GUDID
R20
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

Cleared under the same submission (K160280)

and 8 more cleared under K160280

Similar devices in this category

Other devices filed under MAGNETIC STIMULATORS.

Other devices from Tonica Elektronik A/S

See all devices from Tonica Elektronik A/S →

Properties

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