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TREN

Last updated

01.08.2026 18:27

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Device

2989865

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Certificate

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Active filter:EMDN:W01050103

185 device results listed.

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06974323018667

Treponema Pallidum Antibody Rapid Test Cassette(Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN
CN-MF-000012338
UDI-DI
06974323018667
Basic UDI-DI
B-06974323018667
Reference
IH018
EMDN
W0105010303
EMDN description
SYPHILIS ANTIBODY IGG
First on market country
Germany
Authorised representative
Luxus Lebenswelt GmbH
Last updated
06.07.2026 19:02
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
Treponema Pallidum (TP) Real Time PCR Kit

Treponema Pallidum (TP) Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042229435
Basic UDI-DI
B-06971042229435
Reference
SD-0019-02
EMDN
W0105010305
EMDN description
SYPHILIS DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 12:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Syphilis Test

Syphilis Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
möLab GmbH
Manufacturer SRN
DE-MF-000022941
UDI-DI
D-0270152VK
Basic UDI-DI
B-0270152VK
Reference
0270152
EMDN
W0105010304
EMDN description
SYPHILIS ANTIBODY IGM
First on market country
Germany
Authorised representative
-
Last updated
05.07.2026 16:24
Manufacturer productsView 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
TPHA-DAT ADVANCED

TPHAD

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
DIESSE Diagnostica Senese S.p.A
Manufacturer SRN
IT-MF-000013311
UDI-DI
08033891328429
Basic UDI-DI
803389132TPHAD00ND
Reference
26041
EMDN
W0105010302
EMDN description
SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country
Italy
Authorised representative
-
Last updated
30.06.2026 13:43
Manufacturer productsView details
RPR-DAT ADVANCED

RPRD-A

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent
Manufacturer
DIESSE Diagnostica Senese S.p.A
Manufacturer SRN
IT-MF-000013311
UDI-DI
08033891328412
Basic UDI-DI
803389132RPRD-A00YC
Reference
26031
EMDN
W0105010399
EMDN description
SYPHILIS REAGENTS OTHER
First on market country
Italy
Authorised representative
-
Last updated
30.06.2026 13:43
Manufacturer productsView details
06970301452584

Rapid Test for Antibody to Syphilis (Colloidal Gold Device)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN
CN-MF-000040626
UDI-DI
06970301452584
Basic UDI-DI
B-06970301452584
Reference
WJ-1650, WJ-1650E
EMDN
W0105010302
EMDN description
SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country
Romania
Authorised representative
QbD RepS BV
Last updated
30.06.2026 01:26
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details