Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012356141

FEI Number

3012356141

Entity Name

MEDRES MEDICAL ENGINEERING LTD.

City/State/Country

Biatorbagy Pest, HU

Establishment Address

Banki Donat utca 8., Biatorbagy Pest 2051, HU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MEDRES Medical Engineering Ltd. (Owner Number: 10061418)

Owner / Operator Contact Address

Banki Donat utca 8., Biatorbagy, HU-PE 2051, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aveta Coral Disposable Hysteroscope Aveta Auto Disposable Resecting Device Aveta Pearl Disposable Hysteroscope Aveta Opal Disposable Hysteroscope 4.6mm Aveta Reusable Resecting Handset Aveta Opal Reusable Cable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2019-10-24
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2019-10-24

Official Correspondent

Attila Meretei

US Agent Details

Lyudmila Kokish Kokish Business: Meditrina Inc. Email: lyudmilak@meditrina-inc.com Phone: (408) 4714877

Related Public Records

Same Entity

MEDRES Medical Engineering Ltd.

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
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16
K905706	Circon Acmi	GYN-1500 HYSTEROSCOPIC INUFFLATOR	1991-02-28

Similar Registrations

Registration Number	Establishment Name	Location
3014407293	POLYGON MEDICAL, INC.	Manalapan, NJ, US
3028536560	ORIGYN MEDICAL TECHNOLOGY (HANGZHOU) CO., LTD	Hangzhou Zhejiang, CN
3015972753	STERISERVICE SP. Z O.O.	Czestochowa Slaskie, PL
9611612	PAJUNK GMBH MEDIZINTECHNOLOGIE	GEISINGEN Baden-Wurttemberg, DE
3033902430	OMEC THAI CO.,LTD.	Bang Bo District Samut Prakan, TH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012356141. Last updated year: 2026. Please use registration number 3012356141 when referencing this establishment in official correspondence.