Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012318751

FEI Number

3012318751

Entity Name

DIGITERM LTD.

City/State/Country

Gyongyos Heves, HU

Establishment Address

Ipar ut 7., Gyongyos Heves 3200, HU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIGITERM LTD. (Owner Number: 10051014)

Owner / Operator Contact Address

Ipar ut 7., Gyöngyös, HU-HE 3200, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Comfort-3 Comfort-1 Comfort-2 DiaCare-3 Comfort-4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBB	Chair, Surgical, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2016-01-26

Official Correspondent

GABOR VARGA

US Agent Details

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

Related Public Records

Same Entity

DIGITERM LTD.

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 3012318751. Last updated year: 2026. Please use registration number 3012318751 when referencing this establishment in official correspondence.