- Manufacturer
- CERTEST BIOTEC S.L.
- Manufacturer SRN
- ES-MF-000002193
- UDI-DI
- 08435440217480
- Basic UDI-DI
- 84354402_MDXRESP_HSMYH
- Reference
- VS-HSM101E
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- -
- Authorised representative
- -
- Last updated
- 06.08.2026 22:54
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 20:14
Sync status
Successful
Device
3539394
Actor
47770
Certificate
3395
- Manufacturer
- CERTEST BIOTEC S.L.
- Manufacturer SRN
- ES-MF-000002193
- UDI-DI
- 08435440217497
- Basic UDI-DI
- 84354402_MDXRESP_HSMYH
- Reference
- VS-HSM136E
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- -
- Authorised representative
- -
- Last updated
- 06.08.2026 22:54
- Manufacturer
- CERTEST BIOTEC S.L.
- Manufacturer SRN
- ES-MF-000002193
- UDI-DI
- 08435440217503
- Basic UDI-DI
- 84354402_MDXRESP_HSMYH
- Reference
- VS-HSM172E
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- -
- Authorised representative
- -
- Last updated
- 06.08.2026 22:54
Allplex™ RV Master Assay
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240102084
- Basic UDI-DI
- B-08809240102084
- Reference
- RV10363Z
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 04.08.2026 13:37
Allplex™ RV Master Assay
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240101582
- Basic UDI-DI
- B-08809240101582
- Reference
- RV10307X
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 04.08.2026 13:37
Respiratory Pathogens Combo Testing Kit
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
- Manufacturer SRN
- CN-MF-000013666
- UDI-DI
- 06955931305066
- Basic UDI-DI
- B-06955931305066
- Reference
- 212801
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Italy
- Authorised representative
- Obelis s.a.
- Last updated
- 03.08.2026 22:46
Novel Coronavirus (COVID-19)Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
- Manufacturer
- Sansure Biotech Inc.
- Manufacturer SRN
- CN-MF-000011392
- UDI-DI
- 06955792741522
- Basic UDI-DI
- B-06955792741522
- Reference
- S3326E-24
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- France
- Authorised representative
- Obelis s.a.
- Last updated
- 03.08.2026 22:31
Multiple Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
- Manufacturer
- Sansure Biotech Inc.
- Manufacturer SRN
- CN-MF-000011392
- UDI-DI
- 06955792732735
- Basic UDI-DI
- B-06955792732735
- Reference
- S3163E-48
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- France
- Authorised representative
- Obelis s.a.
- Last updated
- 03.08.2026 21:59
Multiple Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
- Manufacturer
- Sansure Biotech Inc.
- Manufacturer SRN
- CN-MF-000011392
- UDI-DI
- 06955792732728
- Basic UDI-DI
- B-06955792732728
- Reference
- S3163E-24
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- France
- Authorised representative
- Obelis s.a.
- Last updated
- 03.08.2026 21:58
SARS-CoV-2, Influenza Viruses and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
- Manufacturer
- Sansure Biotech Inc.
- Manufacturer SRN
- CN-MF-000011392
- UDI-DI
- 06955792732582
- Basic UDI-DI
- B-06955792732582
- Reference
- S3325E-24
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- France
- Authorised representative
- Obelis s.a.
- Last updated
- 03.08.2026 21:58
SARS-CoV-2, Influenza A and Influenza B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
- Manufacturer
- Sansure Biotech Inc.
- Manufacturer SRN
- CN-MF-000011392
- UDI-DI
- 06955792732001
- Basic UDI-DI
- B-06955792732001
- Reference
- S3324E-24
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- France
- Authorised representative
- Obelis s.a.
- Last updated
- 03.08.2026 21:56
- Manufacturer
- Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
- Manufacturer SRN
- TW-MF-000023414
- UDI-DI
- 04719878570312
- Basic UDI-DI
- B-04719878570312
- Reference
- PCRAE0128
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Italy
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 03.08.2026 09:40
ZENA MAX Respiratory Panel 4 SARS-CoV-2 and Coronavirus (HKU1, NL63, OC43, 229E)
- Manufacturer
- Advanced Molecular Diagnostics Ltd
- Manufacturer SRN
- UK-MF-000043044
- UDI-DI
- 05061059980038
- Basic UDI-DI
- B-05061059980038
- Reference
- KD146104M-100
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Malta
- Authorised representative
- Advena Limited
- Last updated
- 02.08.2026 18:45
ZENA MAX Respiratory Panel 3 SARS-CoV-2, Influenza A&B and H1N1 Real Time PCR Detection Kit
- Manufacturer
- Advanced Molecular Diagnostics Ltd
- Manufacturer SRN
- UK-MF-000043044
- UDI-DI
- 05061059980021
- Basic UDI-DI
- B-05061059980021
- Reference
- KD146103M-100
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Malta
- Authorised representative
- Advena Limited
- Last updated
- 02.08.2026 18:45
ZENA MAX Respiratory Panel 2 SARS-CoV-2, Influenza A & B and RSB A&B Real Time PCR Detection Kit
- Manufacturer
- Advanced Molecular Diagnostics Ltd
- Manufacturer SRN
- UK-MF-000043044
- UDI-DI
- 05061059980014
- Basic UDI-DI
- B-05061059980014
- Reference
- KD146102M-100
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Malta
- Authorised representative
- Advena Limited
- Last updated
- 02.08.2026 18:45
ZENA MAX Respiratory Panel 1 SARS-CoV-2, Influenza A and B Real Time PCR Detection Kit
- Manufacturer
- Advanced Molecular Diagnostics Ltd
- Manufacturer SRN
- UK-MF-000043044
- UDI-DI
- 05061059980007
- Basic UDI-DI
- B-05061059980007
- Reference
- KD146101M-100
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Malta
- Authorised representative
- Advena Limited
- Last updated
- 02.08.2026 18:45
Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method)
- Manufacturer
- Healgen Scientific Limited Liability Company
- Manufacturer SRN
- US-MF-000018839
- UDI-DI
- 00810173656986
- Basic UDI-DI
- B-00810173656986
- Reference
- 2RYT8A01
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Ireland
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 01.08.2026 10:40
- Manufacturer
- Vircell, S.L
- Manufacturer SRN
- ES-MF-000004099
- UDI-DI
- 08436040329900
- Basic UDI-DI
- 843604032RTPCR02101VJ
- Reference
- RTPCR021
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 31.07.2026 22:49
Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P, HRSV a/b Real-Time PCR kit
- Manufacturer
- Poly Diagnostics
- Manufacturer SRN
- LU-MF-000042647
- UDI-DI
- 05430004263500
- Basic UDI-DI
- 5430004263PD2VC
- Reference
- PD2
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- Luxembourg
- Authorised representative
- -
- Last updated
- 31.07.2026 11:13
SARS-COV-2/FLUA/FLUB/RSV R-GENE®
- Manufacturer
- bioMérieux SA
- Manufacturer SRN
- FR-MF-000004436
- UDI-DI
- 03573026631512
- Basic UDI-DI
- 357302BUDI002003SW
- Reference
- 424433
- EMDN
- W0105070503
- EMDN description
- RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- France
- Authorised representative
- -
- Last updated
- 30.07.2026 21:00