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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

31.07.2026 19:58

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Active filter:Manufacturer SRN:DE-MF-000035227

36 device results listed.

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FR475-Fluhunter: SARS-CoV-2 (Realtime PCR-Kit)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430676
Basic UDI-DI: B-04262420430676
Reference: FR475
EMDN: -
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 26.06.2026 22:06

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D0003-DNA-Positive Control for Borrrelia burgdorferi

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430881
Basic UDI-DI: B-04262420430881
Reference: D0003
EMDN: -
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 26.06.2026 22:06

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D0042-Mycoplasma pneumoniae-Positive PCR-Control

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430911
Basic UDI-DI: B-04262420430911
Reference: D0042
EMDN: -
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 26.06.2026 22:06

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D0037-Mycoplasma hominis-Positive PCR-Control

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430942
Basic UDI-DI: B-04262420430942
Reference: D0037
EMDN: -
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 26.06.2026 22:06

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D0020-Ureaplasma urealyticum-Positive PCR-Control

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430973
Basic UDI-DI: B-04262420430973
Reference: D0020
EMDN: -
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 26.06.2026 22:06

Manufacturer products View details

D0035-Mycoplasma genitalium-Positive PCR-Control

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420431000
Basic UDI-DI: B-04262420431000
Reference: D0035
EMDN: -
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 26.06.2026 22:06

Manufacturer products View details

D0046-cDNA positive-Control for Influenza Virus H5

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420431031
Basic UDI-DI: B-04262420431031
Reference: D0046
EMDN: -
EMDN description: AVIAN INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 26.06.2026 22:06

Manufacturer products View details

FR013a-Mycobacterium tuberculosis-Doubel Check (Ready to use Realtime PCR-Kit)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430003
Basic UDI-DI: B-04262420430003
Reference: FR013a
EMDN: -
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.06.2026 22:54

Manufacturer products View details

FR004-Bordetella pertussis (Realtime PCR-Kit)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430027
Basic UDI-DI: B-04262420430027
Reference: FR004
EMDN: -
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.06.2026 22:54

Manufacturer products View details

D0007-DNA Positive Control for Leptospira

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430034
Basic UDI-DI: B-04262420430034
Reference: D0007
EMDN: -
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.06.2026 22:54

Manufacturer products View details

FR325-Zika Virus-Single Check (Realtime PCR-Kit)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430072
Basic UDI-DI: B-04262420430072
Reference: FR325
EMDN: -
EMDN description: ZIKA VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.06.2026 22:54

Manufacturer products View details

FR006-FluHunter: Avian Influenza Virus H5N1 (Realtime PCR-Kit)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430102
Basic UDI-DI: B-04262420430102
Reference: FR006
EMDN: -
EMDN description: AVIAN INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.06.2026 22:54

Manufacturer products View details

FR077-FluHunter-Human swine flu H1N1 (Ready to use Realtime PCR-Kit)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430133
Basic UDI-DI: B-04262420430133
Reference: FR077
EMDN: -
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 22.06.2026 22:54

Manufacturer products View details

FR060-Fluhunter: Influenza A Virus (Ready to use Realtime PCR-Kit)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430164
Basic UDI-DI: B-04262420430164
Reference: FR060
EMDN: -
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 22.06.2026 22:54

Manufacturer products View details

FR074-Dengue Fever Virus -(Realtime PCR-Kit)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430195
Basic UDI-DI: B-04262420430195
Reference: FR074
EMDN: -
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.06.2026 22:54

Manufacturer products View details

FR024-Human Herpes Simplex Virus 1 & 2 -Multiplex (Ready to use Realtime PCR-Kit)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430256
Basic UDI-DI: B-04262420430256
Reference: FR024
EMDN: -
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.06.2026 22:54

Manufacturer products View details