Public EUDAMED Search

EUDAMED Device Search

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

Last updated

08.07.2026 06:23

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Device

2714925

Actor

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Certificate

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Active filter:Certificate number:V76 126886 0005

10 device results listed.

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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
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
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
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
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
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use
Manufacturer
GenSure Biotech Inc.
Manufacturer SRN
CN-MF-000028354
UDI-DI
16976838235352
Basic UDI-DI
697683823P201900F9
Reference
Y2019C01
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
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use
Manufacturer
GenSure Biotech Inc.
Manufacturer SRN
CN-MF-000028354
UDI-DI
16976838235369
Basic UDI-DI
697683823P201900F9
Reference
Y2019C02
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
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use
Manufacturer
GenSure Biotech Inc.
Manufacturer SRN
CN-MF-000028354
UDI-DI
16976838235376
Basic UDI-DI
697683823P201900F9
Reference
Y2019C05
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
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use
Manufacturer
GenSure Biotech Inc.
Manufacturer SRN
CN-MF-000028354
UDI-DI
16976838235383
Basic UDI-DI
697683823P201900F9
Reference
Y2019C10
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
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use
Manufacturer
GenSure Biotech Inc.
Manufacturer SRN
CN-MF-000028354
UDI-DI
16976838235390
Basic UDI-DI
697683823P201900F9
Reference
Y2019C20
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