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Last updated

20.09.2026 12:46

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Active filter:EMDN:W0105010302

111 device results listed.

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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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
Syphilis Antibody Rapid Test

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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
Anti-Treponema Pallidum(Anti-TP) Assay Reagent Kit (CMIA)

C2KJ001

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN
CN-MF-000004716
UDI-DI
06971792050365
Basic UDI-DI
B-06971792050365
Reference
C2KJ001
EMDN
W0105010302
EMDN description
SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 13:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-021 and 90-1028-022

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
bioLytical Laboratories Inc.
Manufacturer SRN
CA-MF-000023304
UDI-DI
00686597202265
Basic UDI-DI
B-00686597202265
Reference
90-1028-021 and 90-1028-022
EMDN
W0105010302
EMDN description
SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country
Netherlands
Authorised representative
Emergo Europe B.V.
Last updated
04.07.2026 18:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-015 and 90-1028-016

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
bioLytical Laboratories Inc.
Manufacturer SRN
CA-MF-000023304
UDI-DI
00686597201640
Basic UDI-DI
B-00686597201640
Reference
90-1028-015 and 90-1028-016
EMDN
W0105010302
EMDN description
SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country
Netherlands
Authorised representative
Emergo Europe B.V.
Last updated
04.07.2026 18:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-017 and 90-1028-018

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
bioLytical Laboratories Inc.
Manufacturer SRN
CA-MF-000023304
UDI-DI
00686597201619
Basic UDI-DI
B-00686597201619
Reference
90-1028-017 and 90-1028-018
EMDN
W0105010302
EMDN description
SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country
Netherlands
Authorised representative
Emergo Europe B.V.
Last updated
04.07.2026 18:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-013 and 90-1028-014

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
bioLytical Laboratories Inc.
Manufacturer SRN
CA-MF-000023304
UDI-DI
00686597201336
Basic UDI-DI
B-00686597201336
Reference
90-1028-013 and 90-1028-014
EMDN
W0105010302
EMDN description
SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country
Netherlands
Authorised representative
Emergo Europe B.V.
Last updated
04.07.2026 18:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-009

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
bioLytical Laboratories Inc.
Manufacturer SRN
CA-MF-000023304
UDI-DI
00686597200490
Basic UDI-DI
B-00686597200490
Reference
90-1028-009
EMDN
W0105010302
EMDN description
SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country
Belgium
Authorised representative
Emergo Europe B.V.
Last updated
04.07.2026 18:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-008

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
bioLytical Laboratories Inc.
Manufacturer SRN
CA-MF-000023304
UDI-DI
00686597200483
Basic UDI-DI
B-00686597200483
Reference
90-1028-008
EMDN
W0105010302
EMDN description
SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country
Netherlands
Authorised representative
Emergo Europe B.V.
Last updated
04.07.2026 18:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-011 and 90-1028-012

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
bioLytical Laboratories Inc.
Manufacturer SRN
CA-MF-000023304
UDI-DI
00686597200278
Basic UDI-DI
B-00686597200278
Reference
90-1028-011 and 90-1028-012
EMDN
W0105010302
EMDN description
SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country
Netherlands
Authorised representative
Emergo Europe B.V.
Last updated
04.07.2026 18:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SERODIA®-TP·PA

100 tests/kit (20×5)

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesProfessional testingReagent
Manufacturer
Zhuhai Livzon Diagnostics Inc.
Manufacturer SRN
CN-MF-000053720
UDI-DI
06935771608411
Basic UDI-DI
6935771608411BB
Reference
A00201100
EMDN
W0105010302
EMDN description
SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country
Belgium
Authorised representative
QbD RepS BV
Last updated
02.07.2026 10:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details