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B.Box Evo

FDA UDIEUDAMED

Class II (US FDA UDI)

by Bemer Int. AG

Identity

Trade Name
B.Box Evo FDA UDI
Generic Name
Hand-held deep-tissue electromagnetic stimulator FDA UDI
Model / Reference
BEMER Therapy System Evo FDA UDI

Identifiers

Catalog Number
424020 FDA UDI
Primary DI / UDI-DI
07640161460706 FDA UDI
510(k) Number
K231368 FDA UDI
FDA Product Code
NGX FDA UDI
GMDN Term
Hand-held deep-tissue electromagnetic stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hand-held deep-tissue electromagnetic stimulator

B.Box Evo by Bemer Int. AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held deep-tissue electromagnetic stimulator.

Cleared under the same submission

K231368 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bemer Int. AG

Sources (2)

  • FDA UDI 4097d7d3-d7d1-42df-ac28-0eb046c92088 34 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026