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Bemer Therapy System

FDA UDI

Class II (US FDA UDI)

by Bemer Int. AG

Identity

Trade Name
Bemer Therapy System FDA UDI
Generic Name
Hand-held deep-tissue electromagnetic stimulator FDA UDI
Model / Reference
B.BODY Professional FDA UDI

Identifiers

Catalog Number
430201 FDA UDI
Primary DI / UDI-DI
07640161461086 FDA UDI
510(k) Number
K210174 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

No

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hand-held deep-tissue electromagnetic stimulator

Bemer Therapy System by Bemer Int. AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bemer Int. AG

Sources (1)

  • FDA UDI 973c3030-78cb-454e-b95d-5ab3cc7baab6 34 fields · synced Jun 8, 2026