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B.Sit Evo

by BEMER Int. AG

Ref 434200

B.Sit Evo (434200) is a hand-held deep-tissue electromagnetic stimulator (EU MDR Class IIa; FDA Class II; FDA product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning) made by Bemer Int. AG, cleared under FDA 510(k) K231368 on 9 Jun 2023, registered in EUDAMED on 28 Feb 2023 (Basic UDI-DI 764016146PEMFD8) and listed in FDA GUDID since 5 Mar 2025 (UDI-DI 07640161460096), active as of 24 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 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07640161460096 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 Number764016146PEMFD8 Basic UDI-DI 07640161460096UDI-DIDate28 Feb 2023RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K231368 decided 9 Jun 2023 Active
  • EUDAMED Basic UDI-DI 764016146PEMFD8 registered 28 Feb 2023 Active
  • FDA GUDID UDI-DI 07640161460096 listed 5 Mar 2025 Listed

Timeline

3 dated events

  1. Registered EUDAMED 764016146PEMFD8
  2. Cleared FDA 510(k) K231368
  3. Listed FDA GUDID 07640161460096

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  • Withdrawn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

Generic name
Hand-held deep-tissue electromagnetic stimulator
Device name
PEMF Applicators
Model / Ref / Catalog
434200, BEMER Therapy System Evo
Primary DI / UDI-DI
07640161460096
Basic UDI-DI
764016146PEMFD8
Direct marketing DI
07640161460096
510(k) Number
FDA product code
NGX
EMDN code
Z12062801 Muscle reinforcement stimulators for innervated muscles
GMDN term
Hand-held deep-tissue electromagnetic stimulator
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
890.5850
EU registration type
Standard device
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
434200
GUDID
BEMER Therapy System Evo
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.

Manufacturer details

EUDAMED SRN
LI-MF-000002555

Similar devices in this category

Other devices filed under MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES.

Other devices from Bemer Int. AG

See all devices from Bemer Int. AG →

Properties

  • Over-the-counter
  • Serial number
Other properties (23, all answered No)