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EUDAMED Device Search

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

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04.08.2026 14:01

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32 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Chaozhou Hybribio Biochemistry Ltd.
Manufacturer SRN: CN-MF-000023818
UDI-DI: 06942221701226
Basic UDI-DI: B-06942221701226
Reference: HBRT-23
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

37 HPV GenoArray Diagnostic Kit

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Chaozhou Hybribio Biochemistry Ltd.
Manufacturer SRN: CN-MF-000023818
UDI-DI: 06942221700472
Basic UDI-DI: B-06942221700472
Reference: HBGA-37
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

48 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Chaozhou Hybribio Biochemistry Ltd.
Manufacturer SRN: CN-MF-000023818
UDI-DI: 06942221700458
Basic UDI-DI: B-06942221700458
Reference: HBRT-H13C
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Chaozhou Hybribio Biochemistry Ltd.
Manufacturer SRN: CN-MF-000023818
UDI-DI: 06942221700441
Basic UDI-DI: B-06942221700441
Reference: HBGA-21
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay)

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223785
Basic UDI-DI: B-06942202223785
Reference: 3013821
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

R98-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571898006
Basic UDI-DI: B-06941571898006
Reference: R98-112
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R97-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571897009
Basic UDI-DI: B-06941571897009
Reference: R97-112
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R95-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571895005
Basic UDI-DI: B-06941571895005
Reference: R95-112
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R94-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571894008
Basic UDI-DI: B-06941571894008
Reference: R94-112
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R93-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571893001
Basic UDI-DI: B-06941571893001
Reference: R93-112
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R92-116

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571892028
Basic UDI-DI: B-06941571892028
Reference: R92-116
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R92-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571892011
Basic UDI-DI: B-06941571892011
Reference: R92-112
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R92-110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571892004
Basic UDI-DI: B-06941571892004
Reference: R92-110
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R90-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571890109
Basic UDI-DI: B-06941571890109
Reference: R90-112
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R90-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571890000
Basic UDI-DI: B-06941571890000
Reference: R90-112
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R89-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571889011
Basic UDI-DI: B-06941571889011
Reference: R89-112
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R89-110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571889004
Basic UDI-DI: B-06941571889004
Reference: R89-110
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R85-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571885013
Basic UDI-DI: B-06941571885013
Reference: R85-112
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R85-110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571885006
Basic UDI-DI: B-06941571885006
Reference: R85-110
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

R84-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571884016
Basic UDI-DI: B-06941571884016
Reference: R84-112
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details