Genekam Biotechnology AG

SRN: DE-MF-000035227 · Duissernstrasse 65a, 47058 Duisburg, Germany

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Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Duissernstrasse 65a, 47058 Duisburg, Germany
Email: [email protected]
Phone: +492035558580
Website: www.genekam.de

Regulatory Overview

Regulation

Eu Ivdd 30

Eu Ivdr 7

Classification

Eu Ivd General 30

Eu Ivd Class A 7

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
D0003-DNA-Positive Control for Borrrelia burgdorferi	EU IVDD	Eu Ivd General	On Market
D0007-DNA Positive Control for Leptospira	EU IVDD	Eu Ivd General	On Market
D0020-Ureaplasma urealyticum-Positive PCR-Control	EU IVDD	Eu Ivd General	On Market
D0035-Mycoplasma genitalium-Positive PCR-Control	EU IVDD	Eu Ivd General	On Market
D0037-Mycoplasma hominis-Positive PCR-Control	EU IVDD	Eu Ivd General	On Market
D0042-Mycoplasma pneumoniae-Positive PCR-Control	EU IVDD	Eu Ivd General	On Market
D0046-cDNA positive-Control for Influenza Virus H5	EU IVDD	Eu Ivd General	On Market
FR001-Leptospira pathogenic (Realtime PCR-Kit)	EU IVDD	Eu Ivd General	On Market
FR004-Bordetella pertussis (Realtime PCR-Kit)	EU IVDD	Eu Ivd General	On Market
FR006-FluHunter: Avian Influenza Virus H5N1 (Realtime PCR-Kit)	EU IVDD	Eu Ivd General	On Market
FR013a-Mycobacterium tuberculosis-Doubel Check (Ready to use Realtime PCR-Kit)	EU IVDD	Eu Ivd General	On Market
FR015-Epstein-Barr Virus (Ready to use Realtime PCR-Kit)	EU IVDD	Eu Ivd General	On Market
FR024-Human Herpes Simplex Virus 1 & 2 -Multiplex (Ready to use Realtime PCR-Kit)	EU IVDD	Eu Ivd General	On Market
FR060-Fluhunter: Influenza A Virus (Ready to use Realtime PCR-Kit)	EU IVDD	Eu Ivd General	On Market
FR074-Dengue Fever Virus -(Realtime PCR-Kit)	EU IVDD	Eu Ivd General	On Market
FR077-FluHunter-Human swine flu H1N1 (Ready to use Realtime PCR-Kit)	EU IVDD	Eu Ivd General	On Market
FR118-Human specific DNA-Internal Control (Realtime PCR-Kit)	EU IVDR	Eu Ivd Class A	On Market
FR166-Yellow Fever Virus -(Realtime PCR-Kit)	EU IVDD	Eu Ivd General	On Market
FR325-Zika Virus-Single Check (Realtime PCR-Kit)	EU IVDD	Eu Ivd General	On Market
FR475-Fluhunter: SARS-CoV-2 (Realtime PCR-Kit)	EU IVDD	Eu Ivd General	On Market
FR799	EU IVDR	Eu Ivd Class A	On Market
FR799-Identification of human specific ß-Actin	EU IVDD	Eu Ivd General	On Market
K011-Mycoplasma pneumoniae (Ready to use PCR-Kit)	EU IVDD	Eu Ivd General	On Market
K012-Mycoplasma genitalium (Ready to use PCR-Kit)	EU IVDD	Eu Ivd General	On Market
K017a-Leptospira pathogenic (Ready to use PCR-Kit)	EU IVDD	Eu Ivd General	On Market
K019-FactorV / Prothrombin	EU IVDD	Eu Ivd General	On Market
K025-Identification of human specific DNA	EU IVDD	Eu Ivd General	On Market
K063-Brucella abortus-Ready to use PCR-Kit	EU IVDD	Eu Ivd General	On Market
K068-Ureaplasma urealyticum (Ready to use PCR-Kit)	EU IVDD	Eu Ivd General	On Market
K201-Plasmodium falciparum	EU IVDD	Eu Ivd General	On Market
K404-Plasmodium vivax	EU IVDD	Eu Ivd General	On Market
K740-Detection of Borrelia burgdorferi	EU IVDD	Eu Ivd General	On Market
SB0001-Genekam Universal DNA-Isolation Kit (INT)	EU IVDR	Eu Ivd Class A	On Market
SB0079-Genekam Universal RNA-Isolation Kit (INT)	EU IVDR	Eu Ivd Class A	On Market
SB0179-Genekam Universal DNA/RNA-Isolation Kit (INT)	EU IVDR	Eu Ivd Class A	On Market
STEM33-ELISA Coating Buffer	EU IVDR	Eu Ivd Class A	On Market
STEM35-ELISA Washing Buffer	EU IVDR	Eu Ivd Class A	On Market