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

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17.07.2026 05:10

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Active filter:Manufacturer SRN:CN-MF-000028354

72 device results listed.

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

P2081C01, P2081C02, P2081C05, P2081C20.

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

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230586
Basic UDI-DI: 697683823P208100FJ
Reference: P2081C01
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Italy
Safety summary (SSCP/SSP): GS/TD-EU-P2081-1403 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:10

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

COVID-19/Flu A+B Ag Rapid Test

P2007C01, P2007C02, P2007C05, P2007C20

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

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230531
Basic UDI-DI: 697683823P200700EQ
Reference: P2007C01
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Italy
Safety summary (SSCP/SSP): GS/TD-EU-P2007-1403 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:10

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

GenSure Strep A Rapid Test

Strep A Rapid Test

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

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230364
Basic UDI-DI: 697683823P201900F9
Reference: P2019C01
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Cyprus
Safety summary (SSCP/SSP): GS/TD-EU-P2019-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:10

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

GenSure Flu A+B Ag Rapid Test

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: 16976838230302
Basic UDI-DI: 697683823P201800F4
Reference: P2018C01
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Cyprus
Safety summary (SSCP/SSP): GS/TD-EU-P2018-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:10

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

GenSure LH Ovulation Rapid Test

P2011C03, P2011C05, P2011C25; P2011M02, P2011M03, P2011M05, P2011M07, P2011M25; P2011S10, P2011S25, P2011S50; Y2011C03, Y2011C05, Y2011C25; Y2011M02, Y2011M03, Y2011M05, Y2011M07, Y2011M25; Y2011S10, Y2011S25, Y2011S50