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118 device results listed.

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Syphilis Rapid Test

GISY

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762135
Basic UDI-DI: B-06976202762135
Reference: GISY-402
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

06975166201490

40 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166201490
Basic UDI-DI: B-06975166201490
Reference: 40 Tests/Kit
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

06975166201483

25 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166201483
Basic UDI-DI: B-06975166201483
Reference: 25 Tests/Kit
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

06975166201476

20 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166201476
Basic UDI-DI: B-06975166201476
Reference: 20 Tests/Kit
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

06975166201469

1 Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166201469
Basic UDI-DI: B-06975166201469
Reference: 1 Test/Kit
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

POCBio Syphilis Antibody Rapid Test

LATB04-C50

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912093778
Basic UDI-DI: B-06974912093778
Reference: LATB04-C50
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

POCBio Syphilis Antibody Rapid Test

LATB04-C25

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912093761
Basic UDI-DI: B-06974912093761
Reference: LATB04-C25
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750495
Basic UDI-DI: B-06974785750495
Reference: ISY-5013
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:43

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Ab Combo Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303971
Basic UDI-DI: B-06974566303971
Reference: SSY-40220
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Ab Combo Rapid Test

50Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303988
Basic UDI-DI: B-06974566303988
Reference: SSY-40250
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Greece
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Ab Combo Rapid Test

1Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303964
Basic UDI-DI: B-06974566303964
Reference: SSY-4021
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

Artron One Step Treponema Pallidum (TP) Antibody Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561123
Basic UDI-DI: B-00628347561123
Reference: A02-09-322
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron One Step Treponema Pallidum (TP) Antibody Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561116
Basic UDI-DI: B-00628347561116
Reference: A02-09-222
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron One Step Treponema Pallidum (TP) Antibody Test

Strip

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561109
Basic UDI-DI: B-00628347561109
Reference: A02-09-213
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex Treponema Pallidum (TP) Antibody Test

Cassette

IVD Class CIVDR 2017/746On the marketKitNear-patient testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561093
Basic UDI-DI: 62834756AL02090279
Reference: AM02-09-322P
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Safety summary (SSCP/SSP): AR-SSP-TP Ab(WB)-2024 · Rev. 06
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

05902643958944

RPR Carbon bez kontroli 100 ozn.

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958944
Basic UDI-DI: 59026439CRTL916RB
Reference: 1-916-1001
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958159

Syfilis kasetki 40 szt.

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958159
Basic UDI-DI: 59026439CRT308JZ
Reference: 1-308-K040
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:26

Manufacturer products View details

AllCheck Syphilis Anti-TP

CHR20

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: CALTH Inc.
Manufacturer SRN: KR-MF-000044697
UDI-DI: 08800061800296
Basic UDI-DI: 88000618W010509CHR20ZL
Reference: CHR20
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Italy
Safety summary (SSCP/SSP): CH-SSP-20 · Rev. 0
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 05:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

RPR-DAT

TREPONEMADAT

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891323936
Basic UDI-DI: 803389132TREPONEMADAT0048
Reference: 26030
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

LYHER

ISY-401-01;ISY-401-05; ISY-401-20; ISY-401-25; ISY-401-40

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412619481
Basic UDI-DI: 697241261ISY-401M9
Reference: ISY-401-01
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details