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100 device results listed.

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2029

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: GIESSE DIAGNOSTICS SRL
Manufacturer SRN: IT-MF-000039031
UDI-DI: 08053172971519
Basic UDI-DI: B-08053172971519
Reference: 2029
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 19:46

Manufacturer products View details

06979878282013

Syphilis Antibody Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878282013
Basic UDI-DI: B-06979878282013
Reference: 1001057
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:51

Manufacturer products Authorised representative products Authorised representative actors View details

06977903341223

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903341223
Basic UDI-DI: B-06977903341223
Reference: GS110205C25
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

06977903341216

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903341216
Basic UDI-DI: B-06977903341216
Reference: GS110205C01
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

The Anti-Treponema Pallidum(Anti-TP) Assay Reagent Kit (CMIA)

C2KC009

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753477823
Basic UDI-DI: B-06976753477823
Reference: C2KC009
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:01

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis (eCLIA)

2×100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984065274
Basic UDI-DI: B-06975984065274
Reference: 0320509812
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:21

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis (eCLIA)

2×50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984065267
Basic UDI-DI: B-06975984065267
Reference: 0320509811
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:21

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis (eCLIA)

50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984065236
Basic UDI-DI: B-06975984065236
Reference: 0320509807
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:21

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis (eCLIA)

100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984065205
Basic UDI-DI: B-06975984065205
Reference: 0320509808
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:21

Manufacturer products Authorised representative products Authorised representative actors View details

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

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986814613
Basic UDI-DI: B-06974986814613
Reference: 100 Tests/Kit
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

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

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986814606
Basic UDI-DI: B-06974986814606
Reference: 50 Tests/Kit
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

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

25 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986814590
Basic UDI-DI: B-06974986814590
Reference: 25 Tests/Kit
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay）

200 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982933
Basic UDI-DI: B-06974969982933
Reference: 200 Tests/kit（DR1140-3）
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay）

100 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982926
Basic UDI-DI: B-06974969982926
Reference: 100 Tests/kit（DR1140-2）
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay）

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982919
Basic UDI-DI: B-06974969982919
Reference: 50 Tests/kit（DR1140-1）
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema pallidum antibodyTest Kit

Treponema pallidum antibody Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620759
Basic UDI-DI: B-06974854620759
Reference: P2202520
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

06974671100236

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100236
Basic UDI-DI: B-06974671100236
Reference: DR-ID-A007
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Antibody Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910667
Basic UDI-DI: B-06974238910667
Reference: HTP063T
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

06973914380947

500 TEST/KIT

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914380947
Basic UDI-DI: B-06973914380947
Reference: H201.02.089C6.020
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 17:47

Manufacturer products Authorised representative products Authorised representative actors View details

06973914380411

100 TEST/KIT

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914380411
Basic UDI-DI: B-06973914380411
Reference: H201.02.089C1.010
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 17:46

Manufacturer products Authorised representative products Authorised representative actors View details