BIOSYSTEMS S.A.

SRN: ES-MF-000000231 · COSTA BRAVA 30, 08030 BARCELONA, Spain

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Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: COSTA BRAVA 30, 08030 BARCELONA, Spain
Email: [email protected]
Phone: +34933110000
Website: www.biosystems.es

Regulatory Overview

Regulation

Eu Ivdr 18

Eu Ivdd 1

Classification

Eu Ivd Class A 18

Eu Ivd General 1

Device Types

Certificate Health

No certificates registered for this manufacturer.

Market Presence

Devices from this manufacturer are available in 10 countries across Europe.

🇧🇬 Bulgaria 🇨🇿 Czechia 🇬🇷 Greece 🇪🇸 Spain 🇭🇷 Croatia 🇮🇹 Italy 🇱🇹 Lithuania 🇵🇱 Poland 🇷🇴 Romania 🇹🇷 Türkiye

Device Portfolio

Name	Regulation	Classification	Market Status
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)	EU IVDR	Eu Ivd Class A	On Market
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)	EU IVDR	Eu Ivd Class A	On Market
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)	EU IVDR	Eu Ivd Class A	On Market
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)	EU IVDR	Eu Ivd Class A	On Market
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)	EU IVDR	Eu Ivd Class A	On Market
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)	EU IVDR	Eu Ivd Class A	On Market
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - CONSUMABLES	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - CONSUMABLES	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - CONSUMABLES	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - CONSUMABLES	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - CONSUMABLES	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - CONSUMABLES	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - CONSUMABLES	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - CONSUMABLES	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY INSTRUMENTS - OTHER	EU IVDR	Eu Ivd Class A	On Market
FAECES COLLECTION DEVICES	EU IVDR	Eu Ivd Class A	On Market
FAECES COLLECTION DEVICES	EU IVDR	Eu Ivd Class A	On Market
IMMUNOCHEMISTRY INSTRUMENTS - OTHER	EU IVDR	Eu Ivd Class A	On Market
LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE	EU IVDR	Eu Ivd Class A	On Market
OPTICAL LABORATORY MICROSCOPES	EU IVDR	Eu Ivd Class A	On Market
SAMPLES ANALYSES, PLASTIC CUVETTES	EU IVDR	Eu Ivd Class A	On Market
URINE CONTROLS	EU IVDD	Eu Ivd General	On Market