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06930317853195

40 tests/kit

IVD Class BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317853195
Basic UDI-DI: 69303178JTJ0640KQC
Reference: DNK-2302-1
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 23.09.2026 02:04

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE Clostridium difficile toxB 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: 08435440203766
Basic UDI-DI: 84354402_MDXGASTROB_CTBQQ
Reference: VS-CTB106L
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 23.09.2026 01:25

Manufacturer products View details

VIASURE Clostridium difficile Real Time PCR Detection Kit

IVD Class BNot specifiedOn the market

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440202998
Basic UDI-DI: 84354402_MDXGASTROB_CDSQA
Reference: VS-CDS106L
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 23.09.2026 01:14

Manufacturer products View details

LyoSens™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276740
Basic UDI-DI: 868499827PCR56Y4
Reference: LYO56WS24
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 17:40

Manufacturer products View details

LyoSens™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276788
Basic UDI-DI: 868499827PCR56Y4
Reference: LYO56WS48
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 17:40

Manufacturer products View details

LyoSens™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276825
Basic UDI-DI: 868499827PCR56Y4
Reference: LYO56WS96
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 17:40

Manufacturer products View details

ChainFor™

Mycoplasma hominis qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032435
Basic UDI-DI: 868499827PCR56Y4
Reference: CFP56P25
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 22.09.2026 17:40

Manufacturer products View details

ChainFor™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032510
Basic UDI-DI: 868499827PCR56Y4
Reference: CFP56P50
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 17:40

Manufacturer products View details

ChainFor™

Mycoplasma hominis qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032428
Basic UDI-DI: 868499827PCR56Y4
Reference: CFP56P100
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 22.09.2026 17:40

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214527332
Basic UDI-DI: 868521452PCR172GD
Reference: LYO172WS24
EMDN: W0105011305
EMDN description: LISTERIA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 12:06

Manufacturer products View details

LyoSens™

LYO172WS48

IVD Class CIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214527356
Basic UDI-DI: 868521452PCR172GD
Reference: LYO172WS48
EMDN: W0105011305
EMDN description: LISTERIA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 22.09.2026 12:06

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214527370
Basic UDI-DI: 868521452PCR172GD
Reference: LYO172WS96
EMDN: W0105011305
EMDN description: LISTERIA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 12:06

Manufacturer products View details

ChainFor™

Listeria monocytogenes qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595035801
Basic UDI-DI: 868521452PCR172GD
Reference: CFP172P25
EMDN: W0105011305
EMDN description: LISTERIA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 22.09.2026 12:06

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595035818
Basic UDI-DI: 868521452PCR172GD
Reference: CFP172P50
EMDN: W0105011305
EMDN description: LISTERIA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 12:06

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595035825
Basic UDI-DI: 868521452PCR172GD
Reference: CFP172P100
EMDN: W0105011305
EMDN description: LISTERIA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 12:05

Manufacturer products View details

AESKULISA® Clostridium tetani IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289511582
Basic UDI-DI: B-04250289511582
Reference: 6102
EMDN: W0105011609
EMDN description: TETANUS (CLOSTRIDIUM T.) - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

Manufacturer products View details

AESKULISA® Borrelia-M

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289501705
Basic UDI-DI: B-04250289501705
Reference: 3803
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

Manufacturer products View details

AESKULISA® Borrelia-G

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289501699
Basic UDI-DI: B-04250289501699
Reference: 3802
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

Manufacturer products View details

SeraSpot® Anti-Treponema-4 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301055
Basic UDI-DI: B-04099466301055
Reference: SP-010-4 G-S12
EMDN: W0105010303
EMDN description: SYPHILIS ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:21

Manufacturer products View details

SeraSpot® Anti-Treponema-4 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301048
Basic UDI-DI: B-04099466301048
Reference: SP-010-4 G-S6
EMDN: W0105010303
EMDN description: SYPHILIS ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:21

Manufacturer products View details