COMPEX, spol. s r.o.

FDA Device Registration & Listing · Brno Mesto Brno, CZ · Registration 3013563737

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013563737
FEI Number
3013563737
Entity Name
COMPEX, spol. s r.o.
City/State/Country
Brno Mesto Brno, CZ
Establishment Address
Palackeho trida 924/105, Brno Mesto Brno 61200, CZ
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
COMPEX, spol. s r.o. (Owner Number: 10054752)
Owner / Operator Contact Address
Palackeho trida 924/105, Brno, CZ-642 61200, CZ
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K240311
PMA Number
N/A

All Registered Proprietary Names

JETT Medical Plasma II JETT Medical II

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QVJ Low Power Electrosurgical Devices For Skin Lesion Destruction General, Plastic Surgery Class 2 878.4400 2023-06-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-02-25

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Packard Business: Medical Device Academy, Inc. Email: rob@fdaestar.com Phone: (802) 2581881

Related Public Records

Same Entity

COMPEX, spol. 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
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013563737. Last updated year: 2026. Please use registration number 3013563737 when referencing this establishment in official correspondence.
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