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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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01.08.2026 18:27

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100 device results listed.

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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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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

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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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View details

Newbio TPHA 100

TPHA

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Newmarket Biomedical Ltd
Manufacturer SRN: GB-MF-000025155
UDI-DI: 05060515140078
Basic UDI-DI: 506051514TPHA7L
Reference: NB007
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 02.07.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View 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 products View details

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 products Authorised representative products Authorised representative actors View details

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: 06970301452577
Basic UDI-DI: B-06970301452577
Reference: WJ-1610, WJ-1610E
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 products Authorised representative products Authorised representative actors View details

WANTAI anti-TP ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452515
Basic UDI-DI: B-06970301452515
Reference: WT-5296
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Hungary
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Syphilis (CLIA)

MAGICL Syphilis (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414735222
Basic UDI-DI: 695441479904KY
Reference: CLIA3062A
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Syphilis (CLIA)

MAGICL Syphilis (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414733372
Basic UDI-DI: 695441479904KY
Reference: CLIA3062A
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Syphilis (CLIA)

MAGICL Syphilis (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414732504
Basic UDI-DI: 695441479904KY
Reference: CLIA3062A
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Syphilis (CLIA)

MAGICL Syphilis (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414732290
Basic UDI-DI: 695441479904KY
Reference: CLIA3062A
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TP Fast Test Kit (Immunofluorescence Assay)

Anti-TP Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414702460
Basic UDI-DI: B-06954414702460
Reference: /
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Antibody Rapid Test Kit

25 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293580835
Basic UDI-DI: 697518250G118343E
Reference: G11834
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details