Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038188186

FEI Number

3038188186

Entity Name

PURTEX S.R.O.

City/State/Country

Zdiby Praha-Vychod, CZ

Establishment Address

Ustecka 103, Zdiby Praha-Vychod 25066, CZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PURTEX s.r.o. (Owner Number: 10092884)

Owner / Operator Contact Address

Ustecka 103, Zdiby, CZ-209 25066, CZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HybriMatt 200

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2025-03-07

Official Correspondent

David Kaszycki

US Agent Details

Steve Krueger Business: MAK and Associates, LLC Email: steve@makcompliance.com Phone: (262) 8946427

Related Public Records

Same Entity

PURTEX s.r.o.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038188186. Last updated year: 2026. Please use registration number 3038188186 when referencing this establishment in official correspondence.