Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009102830

FEI Number

3009102830

Entity Name

BEMER Int. AG

City/State/Country

Triesen, LI

Establishment Address

Austrasse 15, Triesen 9495, LI

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

BEMER Int. AG (Owner Number: 10035841)

Owner / Operator Contact Address

Austrasse 15, Triesen, LI-09 9495, LI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223919

PMA Number

N/A

All Registered Proprietary Names

BEMER Pro-Set, B.BODY, B.SIT, Home-Pack, Go-Pack, Basic-Pack, Office-Pack Light Pack Evo - B.Light Clear Evo and B.Light Restore Evo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-02-10
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-09-25
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2023-09-25

Official Correspondent

Dario Werth

US Agent Details

Matt Dryden Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

BEMER Int. AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31

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3044675848	PEPPER INTERACTIVE INC	Wilmington, DE, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009102830. Last updated year: 2026. Please use registration number 3009102830 when referencing this establishment in official correspondence.