- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000019512
- UDI-DI
- 06973843229416
- Basic UDI-DI
- B-06973843229416
- Reference
- BSJ69S1
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 06.07.2026 17:40
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 16:13
Sync status
Successful
Device
3537745
Actor
47762
Certificate
3388
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Logilet STl Panel
VD4021
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Nanjing Vazyme Medical Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000031032
- UDI-DI
- 06973315739375
- Basic UDI-DI
- B-06973315739375
- Reference
- VD4021
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Spain
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 06.07.2026 17:03
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Nanjing Vazyme Medical Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000031032
- UDI-DI
- 06973315739269
- Basic UDI-DI
- B-06973315739269
- Reference
- DSTI01M
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Spain
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 06.07.2026 17:02
06971532200418
6 Tests/Kit
IVD Annex II List BIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- Guangzhou Hybribio Medicine Technology Ltd.
- Manufacturer SRN
- CN-MF-000027677
- UDI-DI
- 06971532200418
- Basic UDI-DI
- B-06971532200418
- Reference
- HBRT-STD3: CT/NG/UU
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Luxus Lebenswelt GmbH
- Last updated
- 06.07.2026 12:59
06971532200135
48 Tests/Kit
IVD Annex II List BIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- Guangzhou Hybribio Medicine Technology Ltd.
- Manufacturer SRN
- CN-MF-000027677
- UDI-DI
- 06971532200135
- Basic UDI-DI
- B-06971532200135
- Reference
- HBRT-STD3: CT/NG/UU
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Luxus Lebenswelt GmbH
- Last updated
- 06.07.2026 12:59
06970895476065
Urological and Reproductive Tract Microbial Nucleic Acid Test Kit(Fluorescent Probe-Based Real-Time PCR Assay)
IVD generalIVDDOn the marketProfessional testingReagent
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- Manufacturer SRN
- CN-MF-000001539
- UDI-DI
- 06970895476065
- Basic UDI-DI
- B-06970895476065
- Reference
- S08202T2024
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Czechia
- Authorised representative
- Medunion S.L.
- Last updated
- 06.07.2026 11:40
FluoroType® STI VER 1.0
FluoroType® STI VER 1.0
IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Hain Lifescience GmbH
- Manufacturer SRN
- DE-MF-000008606
- UDI-DI
- 04049055003679
- Basic UDI-DI
- B-04049055003679
- Reference
- 1877362
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- -
- Last updated
- 06.07.2026 03:04
14 Kinds of Genitourinary Tract Infection Pathogen Nucleic Acid Detection Kit (Fluorescence PCR)
14 Kinds of Genitourinary Tract Infection Pathogen Nucleic Acid Detection Kit (Fluorescence PCR)
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- Manufacturer SRN
- CN-MF-000012807
- UDI-DI
- D-000012807174097QV
- Basic UDI-DI
- B-000012807174097QV
- Reference
- HWTS-UR040
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Spain
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 04.07.2026 08:59
IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
- Manufacturer
- SpeeDx Pty. Ltd.
- Manufacturer SRN
- AU-MF-000016649
- UDI-DI
- 09352224000078
- Basic UDI-DI
- 9352224011210WD
- Reference
- 1123001
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Netherlands
- Authorised representative
- MedEnvoy Global BV
- Last updated
- 04.07.2026 00:07
TRUPCR® STD Panel Kit
TRUPCR® STD Panel Kit
IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
- Manufacturer
- 3B BlackBio Dx Limited
- Manufacturer SRN
- IN-MF-000023698
- UDI-DI
- 08908015304132
- Basic UDI-DI
- 89080153043B291NQ
- Reference
- 3B291/C
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Wellkang Ltd
- Last updated
- 03.07.2026 22:06
Aptima Combo 2 Assay
Aptima Combo 2 Assay
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045512832
- Basic UDI-DI
- 54200455DIAGAPTCOMBO2P8
- Reference
- PRD-05571
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:06
Aptima CV/TV Assay
Aptima CV/TV Assay
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045512061
- Basic UDI-DI
- 54200455DIAGAPTCVTV2E
- Reference
- PRD-05189
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:06
BIOSYNEX AMPLIQUICK STI Panel I
BIOSYNEX AMPLIQUICK STI Panel I
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- BIOSYNEX
- Manufacturer SRN
- FR-MF-000014073
- UDI-DI
- 03532670103578
- Basic UDI-DI
- 353267F00204P7T
- Reference
- 3150070_SEC01
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- France
- Authorised representative
- -
- Last updated
- 01.07.2026 12:25
Allplex™ NG & DR Assay
Allplex™ NG & DR Assay
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240103685
- Basic UDI-DI
- 924010SD10367H5
- Reference
- SD10368Z
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 01.07.2026 06:13
Allplex™ NG & DR Assay
Allplex™ NG & DR Assay
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240103678
- Basic UDI-DI
- 924010SD10367H5
- Reference
- SD10367X
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 01.07.2026 06:13
Allplex™ STI Essential Assay Q(MH,UU)
Allplex™ STI Essential Assay Q(MH,UU)
IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240103180
- Basic UDI-DI
- 924010SD10202G4
- Reference
- SD10318Z
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 01.07.2026 06:13
Allplex™ CT/NG/MG/TV Assay
Allplex™ CT/NG/MG/TV Assay
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240103173
- Basic UDI-DI
- 924010SD94000KA
- Reference
- SD10317Z
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 01.07.2026 06:13
Allplex™ CT/NG/MG/TV Assay
Allplex™ CT/NG/MG/TV Assay
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240103005
- Basic UDI-DI
- 924010SD94000KA
- Reference
- SD9400X
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 01.07.2026 06:13
Allplex™ CT/NG/MG/TV Assay
Allplex™ CT/NG/MG/TV Assay
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102992
- Basic UDI-DI
- 924010SD94000KA
- Reference
- SD9400Y
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 01.07.2026 06:13
Allplex™ STI Essential Assay Q(MH,UU)
Allplex™ STI Essential Assay Q(MH,UU)
IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102985
- Basic UDI-DI
- 924010SD10202G4
- Reference
- SD10202X
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 01.07.2026 06:13