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MagPro Cool-125

by Tonica Elektronik A/S

Ref 9016E0511

MagPro Cool-125 (9016E0511) 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 3 Nov 2026 (Basic UDI-DI B-05713484020116), cleared under FDA 510(k) K071821 on 27 Jul 2007 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05713484020116), 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) K071821

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-05713484020116 Basic UDI-DI 05713484020116UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05713484020116 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK071821 Date27 Jul 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05713484020116 registered 3 Nov 2026 Active
  • FDA 510(k) K071821 decided 27 Jul 2007 Active
  • FDA GUDID UDI-DI 05713484020116 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K071821
  2. Listed FDA GUDID 05713484020116
  3. Registered EUDAMED B-05713484020116

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  • Withdrawn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
Coil Cool-125 EUDAMED
MagPro GUDID
Generic name
Magnetic neural stimulation system
Model / Ref / Catalog
9016E0511, Cool-125
Primary DI / UDI-DI
05713484020116
Basic UDI-DI
B-05713484020116
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
9016E0511
GUDID
Cool-125
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 (K071821)

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)