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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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06.07.2026 01:04

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Active filter:Manufacturer SRN:CN-MF-000028354

72 device results listed.

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GenSure LH Ovulation Rapid Test

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230227
Basic UDI-DI: 697683823P201100DZ
Reference: P2011C03
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

GenSure LH Ovulation Rapid Test

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230234
Basic UDI-DI: 697683823P201100DZ
Reference: P2011C05
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

GenSure LH Ovulation Rapid Test

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230241
Basic UDI-DI: 697683823P201100DZ
Reference: P2011C25
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

GenSure LH Ovulation Rapid Test

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230265
Basic UDI-DI: 697683823P201100DZ
Reference: P2011S10
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

GenSure LH Ovulation Rapid Test

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230272
Basic UDI-DI: 697683823P201100DZ
Reference: P2011S25
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

GenSure LH Ovulation Rapid Test

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230289
Basic UDI-DI: 697683823P201100DZ
Reference: P2011S50
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

GenSure Flu A+B Ag Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230319
Basic UDI-DI: 697683823P201800F4
Reference: P2018C02
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2018-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

GenSure Flu A+B Ag Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230326
Basic UDI-DI: 697683823P201800F4
Reference: P2018C05
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2018-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

GenSure Flu A+B Ag Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230333
Basic UDI-DI: 697683823P201800F4
Reference: P2018C10
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2018-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

GenSure Flu A+B Ag Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230340
Basic UDI-DI: 697683823P201800F4
Reference: P2018C20
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2018-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

GenSure Strep A Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230371
Basic UDI-DI: 697683823P201900F9
Reference: P2019C02
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2019-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

GenSure Strep A Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230388
Basic UDI-DI: 697683823P201900F9
Reference: P2019C05
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2019-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

GenSure Strep A Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230395
Basic UDI-DI: 697683823P201900F9
Reference: P2019C10
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2019-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

GenSure Strep A Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230401
Basic UDI-DI: 697683823P201900F9
Reference: P2019C20
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2019-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

COVID-19/Flu A+B Ag Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230548
Basic UDI-DI: 697683823P200700EQ
Reference: P2007C02
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2007-1403 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

COVID-19/Flu A+B Ag Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230555
Basic UDI-DI: 697683823P200700EQ
Reference: P2007C05
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2007-1403 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

COVID-19/Flu A+B Ag Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230562
Basic UDI-DI: 697683823P200700EQ
Reference: P2007C20
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2007-1403 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

COVID-19/RSV/Flu A+B Ag Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230593
Basic UDI-DI: 697683823P208100FJ
Reference: P2081C02
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2081-1403 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

COVID-19/RSV/Flu A+B Ag Rapid Test

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230609
Basic UDI-DI: 697683823P208100FJ
Reference: P2081C05
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2081-1403 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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

COVID-19/RSV/Flu A+B Ag Rapid Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230616
Basic UDI-DI: 697683823P208100FJ
Reference: P2081C20
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Safety summary (SSCP/SSP): GS/TD-EU-P2081-1403 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

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