- Manufacturer
- Genes 2Me Private Limited
- Manufacturer SRN
- IN-MF-000035953
- UDI-DI
- D-G2MR172515JP
- Basic UDI-DI
- B-G2MR172515JP
- Reference
- G2MR172515, G2MR170115
- EMDN
- W0105010302
- EMDN description
- SYPHILIS ANTIBODY ASSAYS TOTAL
- First on market country
- Belgium
- Authorised representative
- Obelis s.a.
- Last updated
- 13.07.2026 23:46
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
22.09.2026 04:45
Sync status
Successful
Device
3508798
Actor
47688
Certificate
3340
IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent
Syphilis-Q Real Time PCR Kit
G2M705521
IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent
- Manufacturer
- Genes 2Me Private Limited
- Manufacturer SRN
- IN-MF-000035953
- UDI-DI
- D-G2M705521FP
- Basic UDI-DI
- B-G2M705521FP
- Reference
- G2M705521, G2M705521R
- EMDN
- W0105010305
- EMDN description
- SYPHILIS DETECTION BY NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Obelis s.a.
- Last updated
- 13.07.2026 23:43
D-EIM4205323FL
Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-EIM4205323FL
- Basic UDI-DI
- B-EIM4205323FL
- Reference
- EIM4205323
- EMDN
- W0105010302
- EMDN description
- SYPHILIS ANTIBODY ASSAYS TOTAL
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:53
D-EIM4202323EX
Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-EIM4202323EX
- Basic UDI-DI
- B-EIM4202323EX
- Reference
- EIM4202323
- EMDN
- W0105010302
- EMDN description
- SYPHILIS ANTIBODY ASSAYS TOTAL
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:48
D-EIM4201323EQ
Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-EIM4201323EQ
- Basic UDI-DI
- B-EIM4201323EQ
- Reference
- EIM4201323
- EMDN
- W0105010302
- EMDN description
- SYPHILIS ANTIBODY ASSAYS TOTAL
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:48
Syphilis (TP) Antibody Rapid Test Kit
Syphilis (TP) Antibody Rapid Test Kit
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Synthgene (Yixing) Health Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000054349
- UDI-DI
- D-CNMF000054349CR003G9
- Basic UDI-DI
- B-CNMF000054349CR003G9
- Reference
- CR003
- EMDN
- W0105010302
- EMDN description
- SYPHILIS ANTIBODY ASSAYS TOTAL
- First on market country
- Germany
- Authorised representative
- MedPath GmbH
- Last updated
- 13.07.2026 07:07
Anti-TP Treponema Pallidum Antibody (CLIA)
Anti-TP Treponema Pallidum Antibody (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000028093
- UDI-DI
- D-Anti-TP706-AECQ
- Basic UDI-DI
- B-Anti-TP706-AECQ
- Reference
- Anti-TP706-AE10Y, Anti-TP706-AE10N, Anti-TP706-AE20Y, Anti-TP706-AE20N
- EMDN
- W0105010302
- EMDN description
- SYPHILIS ANTIBODY ASSAYS TOTAL
- First on market country
- Spain
- Authorised representative
- Medunion S.L.
- Last updated
- 12.07.2026 21:46
Gold Standard Diagnostics RPR Reagent Pack
GSD34-1600-R
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Gold Standard Diagnostics, LLC
- Manufacturer SRN
- US-MF-000027142
- UDI-DI
- B350GSD341600R0
- Basic UDI-DI
- B-B350GSD341600R0
- Reference
- GSD34-1600-R
- EMDN
- W0105010399
- EMDN description
- SYPHILIS REAGENTS OTHER
- First on market country
- Germany
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 12.07.2026 21:42
Microtiterplates
GSD-1600-W-CASE
IVD generalIVDDOn the marketProfessional testingSingle use
- Manufacturer
- Gold Standard Diagnostics, LLC
- Manufacturer SRN
- US-MF-000027142
- UDI-DI
- B350GSD1600WCASE0
- Basic UDI-DI
- B-B350GSD1600WCASE0
- Reference
- GSD-1600-W-CASE
- EMDN
- W0105010399
- EMDN description
- SYPHILIS REAGENTS OTHER
- First on market country
- Germany
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 12.07.2026 21:42
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Gold Standard Diagnostics, LLC
- Manufacturer SRN
- US-MF-000027142
- UDI-DI
- B350GSD0116005C0
- Basic UDI-DI
- B-B350GSD0116005C0
- Reference
- GSD01-1600-5C
- EMDN
- W0105010399
- EMDN description
- SYPHILIS REAGENTS OTHER
- First on market country
- Germany
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 12.07.2026 21:42
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Gold Standard Diagnostics, LLC
- Manufacturer SRN
- US-MF-000027142
- UDI-DI
- B350GSD0116000
- Basic UDI-DI
- B-B350GSD0116000
- Reference
- GSD01-1600
- EMDN
- W0105010399
- EMDN description
- SYPHILIS REAGENTS OTHER
- First on market country
- Germany
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 12.07.2026 21:42
D-81649002ATP01HAFU
ATP01-AHG48E/ATP01-AHG96E/ATP01D-AHG48E/ATP01D-AHG96E
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Healgen Scientific Limited Liability Company
- Manufacturer SRN
- US-MF-000018839
- UDI-DI
- D-81649002ATP01HAFU
- Basic UDI-DI
- B-81649002ATP01HAFU
- Reference
- ATP01-AHG48E/ATP01-AHG96E/ATP01D-AHG48E/ATP01D-AHG96E
- EMDN
- W0105010305
- EMDN description
- SYPHILIS DETECTION BY NA REAGENTS
- First on market country
- Germany
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 12.07.2026 10:04
D-81649002ATP01DFBL5
ATP01D-AHG48E/ATP01D-AHG96E
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Healgen Scientific Limited Liability Company
- Manufacturer SRN
- US-MF-000018839
- UDI-DI
- D-81649002ATP01DFBL5
- Basic UDI-DI
- B-81649002ATP01DFBL5
- Reference
- ATP01D-AHG48E/ATP01D-AHG96E
- EMDN
- W0105010305
- EMDN description
- SYPHILIS DETECTION BY NA REAGENTS
- First on market country
- Germany
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 12.07.2026 10:04
Treponema Pallidum Antibody assay (CLIA)
Treponema Pallidum Antibody assay (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000001096
- UDI-DI
- D-7N02F5
- Basic UDI-DI
- B-7N02F5
- Reference
- 7N02V1-B-EU, 7N02U1-B-EU, 7N02P1-B-EU
- EMDN
- W0105010302
- EMDN description
- SYPHILIS ANTIBODY ASSAYS TOTAL
- First on market country
- Germany
- Authorised representative
- MedPath GmbH
- Last updated
- 12.07.2026 09:29
D-400-038-C-MAXQ3
BioGX Syphilis - OSR for BD MAX
IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
- Manufacturer
- BioGX B.V.
- Manufacturer SRN
- NL-MF-000031736
- UDI-DI
- D-400-038-C-MAXQ3
- Basic UDI-DI
- B-400-038-C-MAXQ3
- Reference
- 400-038-C-MAX
- EMDN
- W0105010305
- EMDN description
- SYPHILIS DETECTION BY NA REAGENTS
- First on market country
- Netherlands
- Authorised representative
- -
- Last updated
- 11.07.2026 19:04
IVD Class CNot specifiedOn the market
- Manufacturer
- SHENZHEN YHLO BIOTECH CO., LTD.
- Manufacturer SRN
- CN-MF-000001137
- UDI-DI
- 06925912719014
- Basic UDI-DI
- 692591270114GZ
- Reference
- C88049
- EMDN
- W0105010302
- EMDN description
- SYPHILIS ANTIBODY ASSAYS TOTAL
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 11.07.2026 13:48
IVD Class CNot specifiedOn the market
- Manufacturer
- SHENZHEN YHLO BIOTECH CO., LTD.
- Manufacturer SRN
- CN-MF-000001137
- UDI-DI
- 06925912721598
- Basic UDI-DI
- 692591270114GZ
- Reference
- C88049-S
- EMDN
- W0105010302
- EMDN description
- SYPHILIS ANTIBODY ASSAYS TOTAL
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 11.07.2026 13:48
Treponema Pallidum Antibody Rapid Test
Treponema Pallidum Antibody Rapid Test
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
- Manufacturer SRN
- CN-MF-000013495
- UDI-DI
- 16972698601429
- Basic UDI-DI
- B-16972698601429
- Reference
- P231111
- EMDN
- W0105010302
- EMDN description
- SYPHILIS ANTIBODY ASSAYS TOTAL
- First on market country
- Spain
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 11.07.2026 09:52
IVD generalNot specifiedOn the market
- Manufacturer
- MP Biomedicals Asia Pacific Pte Ltd
- Manufacturer SRN
- SG-MF-000024819
- UDI-DI
- 08887581001051
- Basic UDI-DI
- B-08887581001051
- Reference
- 23560-096
- EMDN
- W0105010302
- EMDN description
- SYPHILIS ANTIBODY ASSAYS TOTAL
- First on market country
- Germany
- Authorised representative
- MP Biomedicals Germany GmbH
- Last updated
- 10.07.2026 17:22
IVD generalNot specifiedOn the market
- Manufacturer
- MP Biomedicals Asia Pacific Pte Ltd
- Manufacturer SRN
- SG-MF-000024819
- UDI-DI
- 08887581001068
- Basic UDI-DI
- B-08887581001068
- Reference
- 23560-480
- EMDN
- W0105010302
- EMDN description
- SYPHILIS ANTIBODY ASSAYS TOTAL
- First on market country
- Germany
- Authorised representative
- MP Biomedicals Germany GmbH
- Last updated
- 10.07.2026 17:22