IGENOMIX SPAIN LAB S.L UNIPERSONAL

SRN: ES-MF-000029287 · Edificios Europark, Parque Tecnológico, Ronda de Narcís Monturiol 11B, 46980 Paterna, Spain

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Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Edificios Europark, Parque Tecnológico, Ronda de Narcís Monturiol 11B, 46980 Paterna, Spain
Email: [email protected]
Website: https://www.igenomix.eu/

Regulatory Overview

Regulation

Eu Ivdr 4

Classification

Eu Ivd Class A 4

Device Types

Certificate Health

No certificates registered for this manufacturer.

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
EMBRACE Kit	EU IVDR	Eu Ivd Class A	On Market
Endometrio Kit	EU IVDR	Eu Ivd Class A	On Market
Kit Blood 1	EU IVDR	Eu Ivd Class A	On Market
Kit Blood 2	EU IVDR	Eu Ivd Class A	On Market
Kit BloodCard	EU IVDR	Eu Ivd Class A	On Market
Kit Buccal swab CR1	EU IVDR	Eu Ivd Class A	On Market
Kit Buccal swab CR2	EU IVDR	Eu Ivd Class A	On Market
Kit Buccal swab SR2	EU IVDR	Eu Ivd Class A	On Market
Kit NIPT	EU IVDR	Eu Ivd Class A	On Market
Kit POC	EU IVDR	Eu Ivd Class A	On Market
Kit POC I	EU IVDR	Eu Ivd Class A	On Market
Kit SAT	EU IVDR	Eu Ivd Class A	On Market
Kit Saliva 1	EU IVDR	Eu Ivd Class A	On Market
Kit Saliva 2	EU IVDR	Eu Ivd Class A	On Market
PGT Kit	EU IVDR	Eu Ivd Class A	On Market
ZENIT by NACE	EU IVDR	Eu Ivd Class A	On Market