Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017271131

FEI Number

3017271131

Entity Name

BIOLUX TECHNOLOGY GMBH

City/State/Country

Absdorf Niederosterreich, AT

Establishment Address

Neubaugasse 31, Absdorf Niederosterreich 3462, AT

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Biolux Technology GmbH (Owner Number: 10049976)

Owner / Operator Contact Address

Neubaugasse 31, Absdorf, AT-NOTA 3462, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230905

PMA Number

N/A

All Registered Proprietary Names

OrthoPulse - Extended - Gen 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PLH	Orthodontic Led Accessory	Dental	Class 2	872.5470	2023-08-28

Official Correspondent

No official correspondent registered.

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

Biolux Technology GmbH

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017271131. Last updated year: 2026. Please use registration number 3017271131 when referencing this establishment in official correspondence.