# B.Body Evo

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/b-body-evo-434300>
- Manufacturer: [BEMER Int. AG](https://devicerts.com/manufacturers/bemer-int-ag) (Liechtenstein)
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: NGX
- EMDN: Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES
- GMDN: Hand-held deep-tissue electromagnetic stimulator (35169)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 07640161460072 · listed 2025-03-05 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K231368 · decision 2023-06-09 · decision SESE · status: Active · from GUDID
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 764016146PEMFD8 · UDI-DI 07640161460072 · registered 2023-02-28 · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: Hand-held deep-tissue electromagnetic stimulator [FDA GUDID (AccessGUDID)]
- Device name: PEMF Applicators [EUDAMED]
- Model / Ref / Catalog: 434300 [EUDAMED, FDA GUDID (AccessGUDID)]; BEMER Therapy System Evo [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 07640161460072 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 764016146PEMFD8 [EUDAMED]
- Direct marketing DI: 07640161460072 [EUDAMED]
- 510(k) Number: K231368 [FDA GUDID (AccessGUDID)]
- FDA product code: NGX [FDA GUDID (AccessGUDID)]
- EMDN code: Z12062801 [EUDAMED]
- GMDN term: Hand-held deep-tissue electromagnetic stimulator (35169) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 890.5850 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Liechtenstein [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Over-the-counter: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: B.Body Evo, BEMER Int. AG. deviCERTS medical device catalogue. https://devicerts.com/devices/b-body-evo-434300 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/b-body-evo-434300.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/b-body-evo-434300
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.