Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030470653

FEI Number

3030470653

Entity Name

SFS GROUP HUNGARY KFT.

City/State/Country

Janossomorja Gyor-Moson-Sopron, HU

Establishment Address

Vasarter utca 18, Janossomorja Gyor-Moson-Sopron 9241, HU

Establishment Type(s)

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

Owner / Operator

SFS Group Hungary Kft. (Owner Number: 10089926)

Owner / Operator Contact Address

Vasarter utca 18, Janossomorja, HU-GS 9241, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OptraGate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2024-01-23

Official Correspondent

Arpad Horvath

US Agent Details

Steven Lee Business: Director of QA/RA, DQM Email: slee@tegramedical.com Phone: (508) 5414296

Related Public Records

Same Entity

SFS Group Hungary Kft.

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

View Entity Profile →

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030470653. Last updated year: 2026. Please use registration number 3030470653 when referencing this establishment in official correspondence.