Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008264458

FEI Number

3008264458

Entity Name

FCARE SYSTEMS NV

City/State/Country

Berchem Antwerpen, BE

Establishment Address

Uitbreidingstraat 42-46, Berchem Antwerpen B-2600, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

fcare Systems NV (Owner Number: 10043355)

Owner / Operator Contact Address

Uitbreidingstraat 42-46, Berchem, BE-VAN 2600, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130283

PMA Number

N/A

All Registered Proprietary Names

Viridex RF ThermaVein EVRF ThermaVein Plus 00MedRF4000US 05SPHERAPROBE 05RAFAELOPROBE F Care RF System Veineo System MedRF4000 CR45iT ThermaVein+ Viridex RF Rafaelo EVRF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONQ	Electrosurgical Coagulation For Aesthetic	General, Plastic Surgery	Class 2	878.4400	2013-02-07
ONQ	Electrosurgical Coagulation For Aesthetic	General, Plastic Surgery	Class 2	878.4400	2025-12-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-12-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-06-09
ONQ	Electrosurgical Coagulation For Aesthetic	General, Plastic Surgery	Class 2	878.4400	2026-03-30

Official Correspondent

No official correspondent registered.

US Agent Details

Patrick Danciu Business: F Care Systems USA LLc Email: pdanciu@fcaresystems.us Phone: (786) 2880740

Related Public Records

Same Entity

fcare Systems NV

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

Similar Registrations

Registration Number	Establishment Name	Location
3010363436	CLASSYS INC	Anyang-si Gyeonggi, KR
3008816935	F CARE SYSTEMS USA	Miami, FL, US
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE
3010709436	Noreaster Medical LLC	Lincoln, RI, US
3007353760	ENERGIST LIMITED	Swansea, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008264458. Last updated year: 2026. Please use registration number 3008264458 when referencing this establishment in official correspondence.