Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003207908

FEI Number

3003207908

Entity Name

GCE, s.r.o.

City/State/Country

Chotebor Havlickuv Brod, CZ

Establishment Address

GCE, s.r.o., Zizkova 381, Chotebor Havlickuv Brod 58301, CZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GCE s.r.o. (Owner Number: 10080413)

Owner / Operator Contact Address

GCE s.r.o., Zizkova 381, Chotebor, CZ-631 58301, CZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GCE Zen-O Lite Portable Oxygen Concentrator Model RS-00600 GCE Zen-O Lite Clarity Portable Oxygen Concentrator Model RS-00600C ARYA ZenO Lite Portable Oxygen Concentrator RS-00600 GCE Zen-O Portable Oxygen Concentrator Model RS-00500 GCE Zen-O Clarity Portable Oxygen Concentrator Model RS-00500C Amvex Flowmeter MediFlowTec MediMeter MediVital E Mediselect II Varimed+ MediReg II MediTec Varimed MediFlow Ultra MediVitop Ministar 2 MediVital

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2021-05-28
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2021-02-02
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2021-02-01

Official Correspondent

Lukas Palek

US Agent Details

Jessica Barrile Business: Ohio Medical, LLC Email: jessica.barrile@ohiomedical.com Phone: (847) 8556318

Related Public Records

Same Entity

GCE s.r.o.

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
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10
K003472	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	2001-06-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

Similar Registrations

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3004964590	AVOX SYSTEMS	Lancaster, NY, US
3008841036	Oxus America, Inc.	Orion Township, MI, US
3016809216	GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.	Guangzhou City Guangdong, CN
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
3013095415	VENTEC LIFE SYSTEMS, INC.	Bothell, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003207908. Last updated year: 2026. Please use registration number 3003207908 when referencing this establishment in official correspondence.