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100 device results listed.

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TP Syphilis Antibody Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062771937
Basic UDI-DI: B-06952062771937
Reference: TP1W-25
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

TP Syphilis Antibody Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062771920
Basic UDI-DI: B-06952062771920
Reference: TP2W-50
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

EIAgen Syphilis Ab Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M52108114LN
Basic UDI-DI: B-++M52108114LN
Reference: 081141 / 081142 / 081145
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 12:48

Manufacturer products View details

OnSite® Syphilis Ab Combo Rapid Test

R0031C

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114460900
Basic UDI-DI: 081011446R0031CD7
Reference: R0031C-25T
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-5146

Treponema Pallidum Antibody Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-5146
Basic UDI-DI: B-TD-HNKX-CED-5146
Reference: /
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX TP Ab CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-TP-02100UY
Basic UDI-DI: B-KR-TP-02100UY
Reference: KR-TP-01200C
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema pallidum (TP) Antibody Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD157XT
Basic UDI-DI: B-GKPD157XT
Reference: GKPD157
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

RapiSyph Rapid Antibody Test kit for Syphilis

G2MR172515

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2MR172515JP
Basic UDI-DI: B-G2MR172515JP
Reference: G2MR172515, G2MR170115
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4205323FL

Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4205323FL
Basic UDI-DI: B-EIM4205323FL
Reference: EIM4205323
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4202323EX

Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4202323EX
Basic UDI-DI: B-EIM4202323EX
Reference: EIM4202323
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4201323EQ

Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4201323EQ
Basic UDI-DI: B-EIM4201323EQ
Reference: EIM4201323
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis (TP) Antibody Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349CR003G9
Basic UDI-DI: B-CNMF000054349CR003G9
Reference: CR003
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TP Treponema Pallidum Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-Anti-TP706-AECQ
Basic UDI-DI: B-Anti-TP706-AECQ
Reference: Anti-TP706-AE10Y, Anti-TP706-AE10N, Anti-TP706-AE20Y, Anti-TP706-AE20N
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 21:46

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Antibody assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7N02F5
Basic UDI-DI: B-7N02F5
Reference: 7N02V1-B-EU, 7N02U1-B-EU, 7N02P1-B-EU
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Anti-TP

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912719014
Basic UDI-DI: 692591270114GZ
Reference: C88049
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Anti-TP

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912721598
Basic UDI-DI: 692591270114GZ
Reference: C88049-S
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601429
Basic UDI-DI: B-16972698601429
Reference: P231111
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics TP ELISA 4.0

IVD generalNot specifiedOn the market

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581001051
Basic UDI-DI: B-08887581001051
Reference: 23560-096
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 10.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics TP ELISA 4.0

IVD generalNot specifiedOn the market

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581001068
Basic UDI-DI: B-08887581001068
Reference: 23560-480
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 10.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

TPHA, 200 tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitReagentSingle use

Manufacturer: Chronolab Systems, S.L.
Manufacturer SRN: ES-MF-000017043
UDI-DI: D-084360385505502EH
Basic UDI-DI: B-084360385505502EH
Reference: 101-0177
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:29

Manufacturer products View details