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

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GeneProof Mycoplasma genitalium/hominis PCR Kit

-

IVD generalNot specifiedOn the market

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161953159
Basic UDI-DI: B-08594161953159
Reference: MGH/ISEX/100
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 06.08.2026 01:04

Manufacturer products View details

Treponema Pallidum Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858113
Basic UDI-DI: B-06933289858113
Reference: W478P0008
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858106
Basic UDI-DI: B-06933289858106
Reference: W478P0007
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858090
Basic UDI-DI: B-06933289858090
Reference: W478P0006
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858083
Basic UDI-DI: B-06933289858083
Reference: W478P0005
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

VIASURE Group A Streptococcus Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440216933
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS101L
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 05.08.2026 23:03

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440216940
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS101H
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:50

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440216957
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS106L
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:50

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440216964
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS106H
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:50

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440216971
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS112L
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:50

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440216988
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS112H
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:50

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440216995
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS113L
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:50

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217008
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS113H
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217046
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS196T
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217015
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS101
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217022
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS136
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217039
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS172
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217053
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS101LE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217060
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS101HE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217077
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS106LE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details