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9 device results listed.

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Saliva Pregnancy Test Kit

1 Test/Kit,2 Tests/kit,5 Tests/kit,20 Tests/

IVD Class BIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565714
Basic UDI-DI: 697454156019LE
Reference: ICA2235
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Finland
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 00:03

Manufacturer products Authorised representative products Authorised representative actors View details

Saliva Pregnancy Test Kit

-

IVD Class BIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565721
Basic UDI-DI: 697454156019LE
Reference: ICA2235
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors View details

Saliva Pregnancy Test Kit

-

IVD Class BIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565738
Basic UDI-DI: 697454156019LE
Reference: ICA2235
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors View details

Saliva Pregnancy Test Kit

-

IVD Class BIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565745
Basic UDI-DI: 697454156019LE
Reference: ICA2235
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors View details

ICA2114-7

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564472
Basic UDI-DI: 697454156017LA
Reference: ICA2114-7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): BTK-CE17-0606 · Rev. A3
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ICA2114-7

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564465
Basic UDI-DI: 697454156017LA
Reference: ICA2114-7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): BTK-CE17-0606 · Rev. A3
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)

ICA2114-7

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564458
Basic UDI-DI: 697454156017LA
Reference: ICA2114-7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): BTK-CE17-0606 · Rev. A3
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)

ICA2114-7

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564441
Basic UDI-DI: 697454156017LA
Reference: ICA2114-7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): BTK-CE17-0606 · Rev. A3
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)

ICA2114-7

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564434
Basic UDI-DI: 697454156017LA
Reference: ICA2114-7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): BTK-CE17-0606 · Rev. A3
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details