Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000369487

FEI Number

1000369487

Entity Name

77 ELEKTRONIKA KFT.

City/State/Country

Budapest, HU

Establishment Address

Fehervari ut 98., Budapest 1116, HU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

77 Elektronika Kft. (Owner Number: 10041281)

Owner / Operator Contact Address

Fehervari ut 98., Budapest, HU-BU 1116, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Urisys 1100

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2012-07-09
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2012-07-09

Official Correspondent

Oliver Babinszki

US Agent Details

Brian Frazier Business: Roche Diagnostics Operations Inc Email: brian.frazier@roche.com Phone: (317) 5214603

Related Public Records

Same Entity

77 Elektronika Kft.

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
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
K162333	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step Fecal Occult Blood (FOB) Test	2017-05-14

Similar Registrations

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1832816	ARKRAY FACTORY USA, INC.	Miami, FL, US
3008517993	ZHEJIANG ORIENT GENE BIOTECH	Huzhou Zhejiang, CN
3005360469	ACRO BIOTECH Inc.	Montclair, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000369487. Last updated year: 2026. Please use registration number 1000369487 when referencing this establishment in official correspondence.