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B.Box Evo BEMER Therapy System Evo

by Bemer Int. AG

B.Box Evo BEMER Therapy System Evo (424020) is a Class II device made by Bemer Int. AG, cleared under FDA 510(k) K231368 on 9 Jun 2023, registered in EUDAMED and listed in FDA GUDID since 5 Mar 2025 (UDI-DI 07640161460706), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231368

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07640161460706 UDI-DI Date5 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231368 Date9 Jun 2023DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K231368 decided 9 Jun 2023 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 07640161460706 listed 5 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231368
  2. Listed FDA GUDID 07640161460706

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  • Withdrawn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
B.Box Evo
Generic name
Hand-held deep-tissue electromagnetic stimulator
Model / Ref / Catalog
BEMER Therapy System Evo, 424020
Primary DI / UDI-DI
07640161460706
510(k) Number
FDA product code
NGX
GMDN term
Hand-held deep-tissue electromagnetic stimulator
Device class
Class II
Regulation number
890.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hand-held deep-tissue electromagnetic stimulator

Cleared under the same submission (K231368)

Similar devices

Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Other devices from Bemer Int. AG

See all devices from Bemer Int. AG →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)