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Logilet Sexual Health Test Panel

DSTI01M

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

Manufacturer products Authorised representative products Authorised representative actors View details

Logilet Gastrointestinal Panel

DGI02M

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739252
Basic UDI-DI: B-06973315739252
Reference: DGI02M
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Logilet Respiratory/Sore Throat (R/ST) Test Panel

DUR01M

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739238
Basic UDI-DI: B-06973315739238
Reference: DUR01M
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

StrongStep® Candida albicans/Trichomonas vaginalis Antigen Combo Rapid Test

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN: CN-MF-000041298
UDI-DI: 06973181850372
Basic UDI-DI: B-06973181850372
Reference: 500060
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

Meningococcus Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042227622
Basic UDI-DI: B-06971042227622
Reference: RD-0058-02
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

Tick-borne Encephalitis Virus (TBEV) Real Time RT-PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042227561
Basic UDI-DI: B-06971042227561
Reference: ER-0172-02
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

Japanese Encephalitis Virus (JEV) Real Time RT-PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042227509
Basic UDI-DI: B-06971042227509
Reference: ER-0065-02
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

20 RP Panel I

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042225048
Basic UDI-DI: B-06971042225048
Reference: R-0027-02P-12A
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

14 RP Panel I

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042225031
Basic UDI-DI: B-06971042225031
Reference: RR-0536-02
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

Salmonella & Shigella Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042224744
Basic UDI-DI: B-06971042224744
Reference: DD-0035-02
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

ToRCH IgM Combo Rapid Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598205358
Basic UDI-DI: B-06942598205358
Reference: ITOM-345
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

Prueba Rápida de Combinación deNorovirus+Rotavirus+Adenovirus+ Astrovirus en Casete

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126113
Basic UDI-DI: B-06936983126113
Reference: IMVD-645
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

MutaPLEX® RespiraScreen 4 DIFF seqc., PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010154
Basic UDI-DI: B-04050598010154
Reference: KG1937-768
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:48

Manufacturer products View details

MutaPLEX® RespiraScreen 4 DIFF seqc., PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010147
Basic UDI-DI: B-04050598010147
Reference: KG1937-384
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:48

Manufacturer products View details

MutaPLEX® RespiraScreen 4 DIFF seqc., PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598009325
Basic UDI-DI: B-04050598009325
Reference: KG193796
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:48

Manufacturer products View details

MutaPlex® RespiraScreen 2 DIFF, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598008014
Basic UDI-DI: B-04050598008014
Reference: KG1928-768
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:46

Manufacturer products View details

MutaPlex® RespiraScreen 2 DIFF, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598008007
Basic UDI-DI: B-04050598008007
Reference: KG1928-384
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:46

Manufacturer products View details