BEUDAMED

EU Manufacturer 🇪🇸 Spain Active

SISTEMAS GENOMICOS. S.L.

SRN: ES-MF-000022949 · C/ RONDA MARCONI 6, 46980 PATERNA, Spain

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Basic UDI-DIs

105

Total Devices

105

On Market

105

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: C/ RONDA MARCONI 6, 46980 PATERNA, Spain
Email: [email protected]
Phone: +34 961 366 150

Regulatory Overview

Regulation

Eu Ivdd 104

Eu Ivdr 1

Classification

Eu Ivd General 103

Eu Ivd Class C 1

Eu Ivd Annex 2 List B 1

Device Types

Certificate Health

Total

Valid

Expiring < 6mo

Expired / Withdrawn

Certificates by Expiry Year

Type	Number	Notified Body	Legislation	Issue Date	Expiry Date	Status
IVDD Annex IV Section 6	2019 03 0883 CT	CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS			May 26, 2023

Market Presence

Devices from this manufacturer are available in 32 countries across Europe.

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

Device Portfolio

Name	Regulation	Classification	Market Status	Certificates
Agile-NIPT for MGI CE-IVD 48 Reacciones.	EU IVDD	Eu Ivd General	On Market	0
CFTR-GeneSGKit 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
COVID-19 MPX 1-Step N Gene PCR H. CE-IVD. Placa 96 reacciones.	EU IVDD	Eu Ivd General	On Market	0
COVID-19 MPX 1-Step N Gene PCR Lyo. CE-IVD. Tubo 96 Reacciones	EU IVDD	Eu Ivd General	On Market	0
COVID-19 MPX 1-Step N Gene PCR. CE-IVD. Tubo 96 Reacciones	EU IVDD	Eu Ivd General	On Market	0
COVID-19 MPX 1-Step NGene PCR Fast CE-IVD Tubo 96 Reacciones	EU IVDD	Eu Ivd General	On Market	0
COVID-19 MPX 1-Step NGene PCR Fast-H CE-IVD Placa 96 Reacciones	EU IVDD	Eu Ivd General	On Market	0
COVID-19 MPX 1-Step NGene PCR Fast-L CE-IVD Placa 96 Reacciones	EU IVDD	Eu Ivd General	On Market	0
COVID-19 MPX 1-Step NGene PCR Lyo-H CE-IVD. Placa 96 Reacciones.	EU IVDD	Eu Ivd General	On Market	0
COVID-19 MPX 1-Step NGene PCR Lyo-L CE-IVD. Placa 96 Reacciones.	EU IVDD	Eu Ivd General	On Market	0
COVID-19 MPX 1-Step NGene PCR-L CE-IVD. Placa 96 Reacciones.	EU IVDD	Eu Ivd General	On Market	0
COVID-19 Multiplex One Step PCR CE-IVD. Tubo 96 Reacciones.	EU IVDD	Eu Ivd General	On Market	0
COVID-19 Multiplex OneStep PCR Lyo-H CE-IVD. Placa 96 Reacciones.	EU IVDD	Eu Ivd General	On Market	0
COVID-19 Multiplex OneStep PCR Lyo-H CE-IVD. Placa 96 Reacciones.	EU IVDD	Eu Ivd General	On Market	0
COVID-19 Multiplex OneStep PCR Lyo-L CE-IVD. Placa 96 Reacciones.	EU IVDD	Eu Ivd General	On Market	0
COVID-19 Multiplex OneStep PCR-H CE-IVD. Placa 96 Reacciones.	EU IVDD	Eu Ivd General	On Market	0
COVID-19 Multiplex OneStep PCR-L. CE-IVD .Placa 96 Reacciones.	EU IVDD	Eu Ivd General	On Market	0
COVID-19 PCR Fast - H CE-IVD Placa 96 Reacciones	EU IVDD	Eu Ivd General	On Market	0
COVID-19 PCR Fast - L CE-IVD Placa 96 Reacciones	EU IVDD	Eu Ivd General	On Market	0
COVID-19 PCR Fast CE-IVD Tubo 96 Reacciones	EU IVDD	Eu Ivd General	On Market	0
COVID-19 PCR Fast Lyo -H CE-IVD Placa 96 Reacciones	EU IVDD	Eu Ivd General	On Market	0
COVID-19 PCR Fast Lyo -L CE-IVD Placa 96 Reacciones	EU IVDD	Eu Ivd General	On Market	0
COVID-19 PCR Fast Lyo CE-IVD Tubo 96 Reacciones	EU IVDD	Eu Ivd General	On Market	0
Cardio-GeneSGKit 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
Cardio-GeneSGKit Arritmias 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
Cardio-GeneSGKit Cvascular 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
Cardio-GeneSGKit DMM 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
Cardio-GeneSGKit MCP 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
Cardio-GeneSGKit X 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
Cardio-GeneSGKit X 48 reacciones	EU IVDD	Eu Ivd General	On Market	0
DI-GeneSGKit 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
DI-GeneSGKit X 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
DI-GeneSGKit X 48 reacciones	EU IVDD	Eu Ivd General	On Market	0
Dislipidemias-GeneSGKit 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
Dislipidemias-GeneSGKit X 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
Dislipidemias-GeneSGKit X 48 reacciones	EU IVDD	Eu Ivd General	On Market	0
Epilepsias-GeneSGKit 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
Epilepsias-GeneSGKit X 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
Epilepsias-GeneSGKit X 48 reacciones	EU IVDD	Eu Ivd General	On Market	0
Genesystems G-NIPT	EU IVDD	Eu Ivd Annex 2 List B	On Market	1
Genesystems© Genebytes	EU IVDD	Eu Ivd General	On Market	0
Genesystems© – G-PRECON	EU IVDD	Eu Ivd General	On Market	0
Glucogenosis-GeneSGKit 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
Glucogenosis-GeneSGKit X 12 reacciones	EU IVDD	Eu Ivd General	On Market	0
Glucogenosis-GeneSGKit X 48 reacciones	EU IVDD	Eu Ivd General	On Market	0
HubExome Focus Panel-GeneSGKit 16 reacciones	EU IVDD	Eu Ivd General	On Market	0
HubExome Focus Panel-GeneSGKit 48 reacciones	EU IVDD	Eu Ivd General	On Market	0
HubExome Plus Panel-GeneSGKit 16 reacciones	EU IVDD	Eu Ivd General	On Market	0
HubExome Plus Panel-GeneSGKit 48 reacciones	EU IVDD	Eu Ivd General	On Market	0
Inmunodeficiencias-GeneSGKit 12 reacciones	EU IVDD	Eu Ivd General	On Market	0

View all 105 devices →

PRRC #1

Name

ALEJANDRO VILLALBA

Country

🇪🇸 Spain

PRRC #2

Name

GUILLERMO LOPEZ

Country

🇪🇸 Spain

Notified Bodies

CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

1 cert

Competent Authority

Name

Agencia Española de Medicamentos y Productos Sanitarios

Country

🇪🇸 Spain

More about this competent authority →

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