Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015751263

FEI Number

3015751263

Entity Name

TESI PRODUCT KFT.

City/State/Country

Budapest, HU

Establishment Address

Rozsa utca 38 / A., Budapest 1077, HU

Establishment Type(s)

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

Owner / Operator

Tesi Product Kft. (Owner Number: 10061010)

Owner / Operator Contact Address

Rozsa utca 38 / A., Budapest, HU-BU 1077, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K041202

PMA Number

N/A

All Registered Proprietary Names

Rapid Test Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYR	Transducer, Gas Pressure, Differential	Anesthesiology	Class 1	868.2875	2024-11-04
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2020-03-27

Official Correspondent

Simon Mitterer

US Agent Details

Celia Parnicky Business: SSPT Inc Email: manager@airshiptrading.com Phone: (954) 2610657

Related Public Records

Same Entity

Tesi Product 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
K162333	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step Fecal Occult Blood (FOB) Test	2017-05-14

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3002637618	Siemens Healthcare Diagnostics Inc	East Walpole, MA, US
2244821	IMMUNOSTICS, INC.	Eatontown, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015751263. Last updated year: 2026. Please use registration number 3015751263 when referencing this establishment in official correspondence.