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EUDAMED Device Search

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

Last updated

22.09.2026 15:09

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Active filter:Manufacturer SRN:CN-MF-000054349

65 device results listed.

Page 3 / 4

MOP Rapid Test Kit(Colloidal gold method)

MOP Rapid Test Kit(Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349DP002G4
Basic UDI-DI
B-CNMF000054349DP002G4
Reference
DP002
EMDN
W0102160599
EMDN description
DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:08
AMP Rapid Test Kit(Colloidal gold method)

AMP Rapid Test Kit(Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349DP001G2
Basic UDI-DI
B-CNMF000054349DP001G2
Reference
DP001
EMDN
W0102160599
EMDN description
DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:08
Strep B Antigen Rapid Test Kit(Colloidal gold method)

Strep B Antigen Rapid Test Kit(Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR057b64
Basic UDI-DI
B-CNMF000054349CR057b64
Reference
CR057
EMDN
W0105090104
EMDN description
STREP. B - RT & POC
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:08
Malaria Antigen Rapid Test Kit (Colloidal gold method)

Malaria Antigen Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR051GL
Basic UDI-DI
B-CNMF000054349CR051GL
Reference
CR051
EMDN
W0105050209
EMDN description
PLASMODIUM (MALARIA)
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:08
Malaria pf/pan Rapid Test Kit(Colloidal gold method)

Malaria pf/pan Rapid Test Kit(Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR057GY
Basic UDI-DI
B-CNMF000054349CR057GY
Reference
CR057
EMDN
W0105050209
EMDN description
PLASMODIUM (MALARIA)
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:08
RSV Antigen Rapid Test Kit(Colloidal gold method)

RSV Antigen Rapid Test Kit(Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR044GP
Basic UDI-DI
B-CNMF000054349CR044GP
Reference
CR044
EMDN
W0105099002
EMDN description
RSV - RT & POC
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:08
Malaria Antibody Rapid Test Kit (Colloidal gold method)

Malaria Antibody Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR046GT
Basic UDI-DI
B-CNMF000054349CR046GT
Reference
CR046
EMDN
W0105050209
EMDN description
PLASMODIUM (MALARIA)
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:08
Bacterial vaginosis Rapid Test Kit (Colloidal gold method)

Bacterial vaginosis Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR028GR
Basic UDI-DI
B-CNMF000054349CR028GR
Reference
CR028
EMDN
W0105070203
EMDN description
GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
Trichomonas/Candida Antigen Combo Rapid Test Kit (Colloidal gold method)

Trichomonas/Candida Antigen Combo Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR027GP
Basic UDI-DI
B-CNMF000054349CR027GP
Reference
CR027
EMDN
W0105070203
EMDN description
GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
Trichomonas Vaginalis Antigen Rapid Test Kit (Colloidal gold method)

Trichomonas Vaginalis Antigen Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR026GM
Basic UDI-DI
B-CNMF000054349CR026GM
Reference
CR026
EMDN
W0105070203
EMDN description
GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
Candida Albicans Antigen Rapid Test Kit (Colloidal gold method)

Candida Albicans Antigen Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR025GK
Basic UDI-DI
B-CNMF000054349CR025GK
Reference
CR025
EMDN
W0105070203
EMDN description
GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
Strep A Antigen Rapid Test Kit (Colloidal gold method)

Strep A Antigen Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR023GF
Basic UDI-DI
B-CNMF000054349CR023GF
Reference
CR023
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
Dengue NS1 Rapid Test Kit (Colloidal gold method)

Dengue NS1 Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR022GD
Basic UDI-DI
B-CNMF000054349CR022GD
Reference
CR022
EMDN
W0105040611
EMDN description
DENGUE VIRUS
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
Typhoid Antigen Rapid Test Kit (Colloidal gold method)

Typhoid Antigen Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR021GB
Basic UDI-DI
B-CNMF000054349CR021GB
Reference
CR021
EMDN
W0105090199
EMDN description
BACTERIOLOGY - RT & POC - OTHER
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
Typhoid IgG/IgM Rapid Test Kit (Colloidal gold method)

Typhoid IgG/IgM Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR020G9
Basic UDI-DI
B-CNMF000054349CR020G9
Reference
CR020
EMDN
W0105090199
EMDN description
BACTERIOLOGY - RT & POC - OTHER
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
Monkeypox Virus Antigen Rapid Test Kit

Monkeypox Virus Antigen Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR017GL
Basic UDI-DI
B-CNMF000054349CR017GL
Reference
CR017
EMDN
W0105099008
EMDN description
MONKEYPOX VIRUS / MPOX RT & POC
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
Monkeypox Virus Antibody Rapid Test Kit

Monkeypox Virus Antibody Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR015GG
Basic UDI-DI
B-CNMF000054349CR015GG
Reference
CR015
EMDN
W0105099008
EMDN description
MONKEYPOX VIRUS / MPOX RT & POC
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)

Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR011G8
Basic UDI-DI
B-CNMF000054349CR011G8
Reference
CR011
EMDN
W0105040611
EMDN description
DENGUE VIRUS
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
Dengue IgG/IgM Rapid Test Kit (Colloidal gold method)

Dengue IgG/IgM Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR010G6
Basic UDI-DI
B-CNMF000054349CR010G6
Reference
CR010
EMDN
W0105040611
EMDN description
DENGUE VIRUS
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
FOB Rapid Test Kit

FOB Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR009GM
Basic UDI-DI
B-CNMF000054349CR009GM
Reference
CR009
EMDN
W01021699
EMDN description
RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07