Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015925378

FEI Number

3015925378

Entity Name

KH Czechia s.r.o.

City/State/Country

Chodov Sokolov, CZ

Establishment Address

Vintirovska 1157, Chodov Sokolov 35735, CZ

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Kunststoff Helmbrechts AG (Owner Number: 10059824)

Owner / Operator Contact Address

Pressecker Str. 39, Helmbrechts, DE-NOTA 95233, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CMOS Video Esophagoscope SSU Flexible Intubation Video Endoscope Sterile (FIVE-S) Flexible Video-Uretero-Renoscope SSU System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2020-02-03
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-01-25
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-01-25

Official Correspondent

No official correspondent registered.

US Agent Details

Alfred Lerch Business: confinis USA Inc. Email: usagent@confinis.com Phone: (910) 2289391

Related Public Records

Same Entity

Kunststoff Helmbrechts AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008439484	KUNSTSTOFF HELMBRECHTS AG	Helmbrechts Bavaria, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

Similar Registrations

Registration Number	Establishment Name	Location
3010707607	KARL STORZ SE & CO. KG	NEUHAUSEN OBECK Baden-Wurttemberg, DE
9612501	Covidien	- Santo Domingo, DO
3016490370	LUCID DIAGNOSTICS, INC.	Foxborough, MA, US
9610617	KARL STORZ SE & CO. KG	TUTTLINGEN Baden-Wurttemberg, DE
3018094310	Medtronic Engineering and Innovation Center (MEIC)	Hyderabad Telangana, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015925378. Last updated year: 2026. Please use registration number 3015925378 when referencing this establishment in official correspondence.