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TREN

Last updated

25.09.2026 20:00

Sync status

Successful

Device

3655821

Actor

47941

Certificate

3412

Active filter:Certificate number:V76 126886 0005

13 device results listed.

Page 1 / 1

CSVXML
DyonStrepA 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
06976838234891
Basic UDI-DI
697683823P201900F9
Reference
P2019C01
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Greece
Safety summary (SSCP/SSP)
GS/TD-EU-P2019-901 · Rev. A/2
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
24.09.2026 06:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
DIAGOTEC 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
06976838234907
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
21.09.2026 22:23
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
DIAGOTEC 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
06976838234914
Basic UDI-DI
697683823P201900F9
Reference
P2019C01
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
21.09.2026 22:23
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView 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 productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
GenSure 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
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 productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
GenSure 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
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 productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
GenSure 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
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 productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
GenSure 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
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 productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
EuroGen 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
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
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
EuroGen 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
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
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
EuroGen 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
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
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
EuroGen 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
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
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
EuroGen 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
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
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details