Public EUDAMED Search

EUDAMED Device Search

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

Last updated

21.09.2026 19:01

Sync status

Successful

Device

3152549

Actor

47651

Certificate

3295

Active filter:Manufacturer SRN:DE-MF-000035227

36 device results listed.

Page 1 / 2

D0046-cDNA positive-Control for Influenza Virus H5

D0046-cDNA positive-Control for Influenza Virus H5

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420431031
Basic UDI-DI
B-04262420431031
Reference
D0046
EMDN
W0105040515
EMDN description
AVIAN INFLUENZA - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:45
D0035-Mycoplasma genitalium-Positive PCR-Control

D0035-Mycoplasma genitalium-Positive PCR-Control

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420431000
Basic UDI-DI
B-04262420431000
Reference
D0035
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:45
D0020-Ureaplasma urealyticum-Positive PCR-Control

D0020-Ureaplasma urealyticum-Positive PCR-Control

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430973
Basic UDI-DI
B-04262420430973
Reference
D0020
EMDN
W0105011699
EMDN description
BACTERIOLOGY - NA REAGENTS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:45
D0037-Mycoplasma hominis-Positive PCR-Control

D0037-Mycoplasma hominis-Positive PCR-Control

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430942
Basic UDI-DI
B-04262420430942
Reference
D0037
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:45
D0042-Mycoplasma pneumoniae-Positive PCR-Control

D0042-Mycoplasma pneumoniae-Positive PCR-Control

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430911
Basic UDI-DI
B-04262420430911
Reference
D0042
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:45
D0003-DNA-Positive Control for Borrrelia burgdorferi

D0003-DNA-Positive Control for Borrrelia burgdorferi

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430881
Basic UDI-DI
B-04262420430881
Reference
D0003
EMDN
W0105010605
EMDN description
LYME DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:45
FR475-Fluhunter: SARS-CoV-2 (Realtime PCR-Kit)

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

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430676
Basic UDI-DI
B-04262420430676
Reference
FR475
EMDN
W0105040519
EMDN description
CORONAVIRUS - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:45
K404-Plasmodium vivax

K404-Plasmodium vivax

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430645
Basic UDI-DI
B-04262420430645
Reference
K404
EMDN
W0105050209
EMDN description
PLASMODIUM (MALARIA)
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
K201-Plasmodium falciparum

K201-Plasmodium falciparum

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430614
Basic UDI-DI
B-04262420430614
Reference
K201
EMDN
W0105050209
EMDN description
PLASMODIUM (MALARIA)
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
K063-Brucella abortus-Ready to use PCR-Kit

K063-Brucella abortus-Ready to use PCR-Kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430584
Basic UDI-DI
B-04262420430584
Reference
K063
EMDN
W0105011601
EMDN description
BRUCELLA - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
K068-Ureaplasma urealyticum (Ready to use PCR-Kit)

K068-Ureaplasma urealyticum (Ready to use PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430553
Basic UDI-DI
B-04262420430553
Reference
K068
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
K012-Mycoplasma genitalium (Ready to use PCR-Kit)

K012-Mycoplasma genitalium (Ready to use PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430522
Basic UDI-DI
B-04262420430522
Reference
K012
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
K011-Mycoplasma pneumoniae (Ready to use PCR-Kit)

K011-Mycoplasma pneumoniae (Ready to use PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430492
Basic UDI-DI
B-04262420430492
Reference
K011
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
K017a-Leptospira pathogenic (Ready to use PCR-Kit)

K017a-Leptospira pathogenic (Ready to use PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430461
Basic UDI-DI
B-04262420430461
Reference
K017a
EMDN
W0105011604
EMDN description
LEPTOSPIRA - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
K740-Detection of Borrelia burgdorferi

K740-Detection of Borrelia burgdorferi

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430430
Basic UDI-DI
B-04262420430430
Reference
K740
EMDN
W0105010605
EMDN description
LYME DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
K019-FactorV / Prothrombin

K019-Factor V / Prothrombin

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430409
Basic UDI-DI
B-04262420430409
Reference
K019
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
K025-Identification of human specific DNA

K025-Identification of human specific DNA

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430379
Basic UDI-DI
B-04262420430379
Reference
K025
EMDN
W0105080908
EMDN description
STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
FR015-Epstein-Barr Virus (Ready to use Realtime PCR-Kit)

FR015-Epstein-Barr Virus (Ready to use Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430317
Basic UDI-DI
B-04262420430317
Reference
FR015
EMDN
W0105040403
EMDN description
EBV - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
FR001-Leptospira pathogenic (Realtime PCR-Kit)

FR001-Leptospira pathogenic (Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430287
Basic UDI-DI
B-04262420430287
Reference
FR001
EMDN
W0105011604
EMDN description
LEPTOSPIRA - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
FR060-Fluhunter: Influenza A Virus (Ready to use Realtime PCR-Kit)

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

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430164
Basic UDI-DI
B-04262420430164
Reference
FR060
EMDN
W0105040599
EMDN description
VIROLOGY - NA REAGENTS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44