- Manufacturer
- Vela Operations Singapore Pte. Ltd.
- Manufacturer SRN
- SG-MF-000025684
- UDI-DI
- 08885013953107
- Basic UDI-DI
- B-08885013953107
- Reference
- 300145
- EMDN
- W0105040504
- EMDN description
- INFLUENZA & PARA INFLUENZA - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Vela Diagnostics Germany GmbH
- Last updated
- 10.07.2026 17:16
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
IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
- Manufacturer SRN
- SG-MF-000025684
- UDI-DI
- 08885013953039
- Basic UDI-DI
- B-08885013953039
- Reference
- 300192
- EMDN
- W0105040506
- EMDN description
- ROTAVIRUS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Vela Diagnostics Germany GmbH
- Last updated
- 10.07.2026 17:16
IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
- Manufacturer SRN
- SG-MF-000025684
- UDI-DI
- 08885013953015
- Basic UDI-DI
- B-08885013953015
- Reference
- 300202
- EMDN
- W0105040516
- EMDN description
- NOROVIRUS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Vela Diagnostics Germany GmbH
- Last updated
- 10.07.2026 17:16
En-swer™ COVID-19 RT-PCR Kit
En-swer™ COVID-19 RT- PCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- NanoEntek, Inc.
- Manufacturer SRN
- KR-MF-000021903
- UDI-DI
- 08809317540856
- Basic UDI-DI
- B-08809317540856
- Reference
- EPCO19100
- EMDN
- W0105040599
- EMDN description
- VIROLOGY - NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 13:42
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204302052
- Basic UDI-DI
- B-08800204302052
- Reference
- RV015
- EMDN
- W0105040599
- EMDN description
- VIROLOGY - NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:15
08800204300652
RADI STI-10 Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300652
- Basic UDI-DI
- B-08800204300652
- Reference
- RS001
- EMDN
- W0105040599
- EMDN description
- VIROLOGY - NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:15
08800204300645
RADI MTB Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300645
- Basic UDI-DI
- B-08800204300645
- Reference
- RB008
- EMDN
- W0105040599
- EMDN description
- VIROLOGY - NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:15
08800204300621
RADI Monkeypox Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300621
- Basic UDI-DI
- B-08800204300621
- Reference
- RV015
- EMDN
- W0105040599
- EMDN description
- VIROLOGY - NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14
08800204300614
RADI Chikungunya Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300614
- Basic UDI-DI
- B-08800204300614
- Reference
- RV014
- EMDN
- W0105040525
- EMDN description
- CHIKUNGUNYA VIRUS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14
08800204300607
RADI CDZ Virus Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300607
- Basic UDI-DI
- B-08800204300607
- Reference
- RV007
- EMDN
- W0105040599
- EMDN description
- VIROLOGY - NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14
08800204300591
RADI West nile virus Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300591
- Basic UDI-DI
- B-08800204300591
- Reference
- RV005
- EMDN
- W0105040526
- EMDN description
- WEST NILE VIRUS - NA REAGENT
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14
08800204300270
RADI Vibrio cholera Detection KIT
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300270
- Basic UDI-DI
- B-08800204300270
- Reference
- RB004
- EMDN
- W0105040599
- EMDN description
- VIROLOGY - NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14
08800204300225
RADI FAST RSV A/B Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300225
- Basic UDI-DI
- B-08800204300225
- Reference
- RV012F
- EMDN
- W0105040505
- EMDN description
- RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14
08800204300195
RADI Flu-SC2 Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300195
- Basic UDI-DI
- B-08800204300195
- Reference
- RV009
- EMDN
- W0105040599
- EMDN description
- VIROLOGY - NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14
08800204300188
RADI Yellow Fever Virus Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300188
- Basic UDI-DI
- B-08800204300188
- Reference
- RV004
- EMDN
- W0105040599
- EMDN description
- VIROLOGY - NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14
08800204300201
RADI FAST Influenza A/B Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300201
- Basic UDI-DI
- B-08800204300201
- Reference
- RV011F
- EMDN
- W0105040504
- EMDN description
- INFLUENZA & PARA INFLUENZA - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14
08800204300171
RADI Ebola Virus Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300171
- Basic UDI-DI
- B-08800204300171
- Reference
- RV003
- EMDN
- W0105040528
- EMDN description
- EBOLA (FILOVIRUS) - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14
08800204300164
RADI Dengue Virus Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300164
- Basic UDI-DI
- B-08800204300164
- Reference
- RV002
- EMDN
- W0105040511
- EMDN description
- DENGUE VIRUS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14
08800204300157
RADI Rift Valley Fever Virus Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300157
- Basic UDI-DI
- B-08800204300157
- Reference
- RV001
- EMDN
- W0105040599
- EMDN description
- VIROLOGY - NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14
08800204300072
RADI FAST COVID-19 Detection Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- KH Medical Co., Ltd.
- Manufacturer SRN
- KR-MF-000017883
- UDI-DI
- 08800204300072
- Basic UDI-DI
- B-08800204300072
- Reference
- RV008F
- EMDN
- W0105040599
- EMDN description
- VIROLOGY - NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 08:14