- Manufacturer
- Vela Operations Singapore Pte. Ltd.
- Manufacturer SRN
- SG-MF-000025684
- UDI-DI
- 08885013953848
- Basic UDI-DI
- B-08885013953848
- Reference
- 301074
- EMDN
- W0105070304
- EMDN description
- INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Vela Diagnostics Germany GmbH
- Last updated
- 10.07.2026 17:17
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
23.09.2026 04:15
Sync status
Successful
Device
3540243
Actor
47787
Certificate
3399
IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use
08809446081879
MST-N05082
IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- WELLS BIO, INC.
- Manufacturer SRN
- KR-MF-000031789
- UDI-DI
- 08809446081879
- Basic UDI-DI
- B-08809446081879
- Reference
- MST-N05082
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Greece
- Authorised representative
- MDSS GmbH
- Last updated
- 10.07.2026 14:10
08809446080636
MST-N10082
IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- WELLS BIO, INC.
- Manufacturer SRN
- KR-MF-000031789
- UDI-DI
- 08809446080636
- Basic UDI-DI
- B-08809446080636
- Reference
- MST-N10082
- EMDN
- W0105070501
- EMDN description
- STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
- First on market country
- Greece
- Authorised representative
- MDSS GmbH
- Last updated
- 10.07.2026 14:09
Anyplex™ II STI-7e Detection
Anyplex™ II STI-7e Detection
IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240103234
- Basic UDI-DI
- B-08809240103234
- Reference
- SD10323Z
- 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
- 10.07.2026 12:45
Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay
Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240103043
- Basic UDI-DI
- B-08809240103043
- Reference
- RV10349Z
- EMDN
- W0105070304
- EMDN description
- INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:45
Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay
Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240103036
- Basic UDI-DI
- B-08809240103036
- Reference
- RV10259X
- EMDN
- W0105070304
- EMDN description
- INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:45
Allplex™ Respiratory Panel 1A
Allplex™ Respiratory Panel 1A
IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102664
- Basic UDI-DI
- B-08809240102664
- Reference
- RP9702Y
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:45
Allplex™ Respiratory Panel 1A
Allplex™ Respiratory Panel 1A
IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102657
- Basic UDI-DI
- B-08809240102657
- Reference
- RP10231Z
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:45
Allplex™ Respiratory Panel 1A
Allplex™ Respiratory Panel 1A
IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102640
- Basic UDI-DI
- B-08809240102640
- Reference
- RP9702X
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:45
Allplex™ Respiratory Panel 2
Allplex™ Respiratory Panel 2
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102374
- Basic UDI-DI
- B-08809240102374
- Reference
- RP10180Z
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:45
Allplex™ Respiratory Panel 2
Allplex™ Respiratory Panel 2
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102367
- Basic UDI-DI
- B-08809240102367
- Reference
- RP9802Y
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:45
Allplex™ Respiratory Panel 2
Allplex™ Respiratory Panel 2
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102350
- Basic UDI-DI
- B-08809240102350
- Reference
- RP9802X
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:45
Allplex™ Meningitis-B Assay
Allplex™ Meningitis-B Assay
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102114
- Basic UDI-DI
- B-08809240102114
- Reference
- MG10211Z
- EMDN
- W0105070505
- EMDN description
- MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:45
Allplex™ Meningitis-V2 Assay
Allplex™ Meningitis-V2 Assay
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102107
- Basic UDI-DI
- B-08809240102107
- Reference
- MG10210Z
- EMDN
- W0105070505
- EMDN description
- MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:45
Allplex™ Meningitis-V1 Assay
Allplex™ Meningitis-V1 Assay
IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102091
- Basic UDI-DI
- B-08809240102091
- Reference
- MG10209Z
- EMDN
- W0105070505
- EMDN description
- MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:45
Allplex™ GI-Bacteria(I) Assay
Allplex™ GI-Bacteria(I) Assay
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102015
- Basic UDI-DI
- B-08809240102015
- Reference
- GI10201Z
- EMDN
- W0105070504
- EMDN description
- GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:44
Allplex™ GI-EB Screening Assay
Allplex™ GI-EB Screening Assay
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240101988
- Basic UDI-DI
- B-08809240101988
- Reference
- GI10198X
- EMDN
- W0105070504
- EMDN description
- GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:44
Allplex™ GI-EB Screening Assay
Allplex™ GI-EB Screening Assay
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240101971
- Basic UDI-DI
- B-08809240101971
- Reference
- GI10197Y
- EMDN
- W0105070504
- EMDN description
- GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:44
Allplex™ GI-EB Screening Assay
Allplex™ GI-EB Screening Assay
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240101964
- Basic UDI-DI
- B-08809240101964
- Reference
- GI10196Z
- EMDN
- W0105070504
- EMDN description
- GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:44
Allplex™ GI-Virus plus Assay
Allplex™ GI-Virus plus Assay
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240101889
- Basic UDI-DI
- B-08809240101889
- Reference
- GI10188X
- EMDN
- W0105070504
- EMDN description
- GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:44