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SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348761042
Basic UDI-DI: B-06971348761042
Reference: MF-68-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)

MF-71-25

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760854
Basic UDI-DI: B-06971348760854
Reference: MF-71
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 & Influenza A/B Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)

MF-69-25

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760755
Basic UDI-DI: B-06971348760755
Reference: MF-69
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760151
Basic UDI-DI: B-06971348760151
Reference: MF-91-5
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Real-time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225937331
Basic UDI-DI: B-06971225937331
Reference: GPCR130024
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Real-time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225937225
Basic UDI-DI: B-06971225937225
Reference: GPCR130048
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Real-time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936402
Basic UDI-DI: B-06971225936402
Reference: GPCR130096
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06971100211396

Type A, Type B.

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: 06971100211396
Basic UDI-DI: B-06971100211396
Reference: A1C320020005, A1C320020015
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

06971100211389

Type A, Type B, Type C

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: 06971100211389
Basic UDI-DI: B-06971100211389
Reference: A1A325020007, A1A325020019, A1A325020031
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

06971100211372

Type A, Type B, Type C

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: 06971100211372
Basic UDI-DI: B-06971100211372
Reference: A1A324020007，A1A324020019，A1A324020031
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Dispositivo de Prueba Rápida para Chikungunya IgG/IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126274
Basic UDI-DI: B-06936983126274
Reference: ICHI-402
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

Prueba Rápida de Mononucleosis en Casete

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126212
Basic UDI-DI: B-06936983126212
Reference: IMO-402
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Flu Neo 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815005719
Basic UDI-DI: B-04987815005719
Reference: CAFL0571
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 06.07.2026 08:10

Manufacturer products Authorised representative products Authorised representative actors View details

Toda Infludiag A&B

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309510125
Basic UDI-DI: B-03760309510125
Reference: 1061
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:58

Manufacturer products View details

BIOSYNEX RSVTOP BSS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03700531700383
Basic UDI-DI: B-03700531700383
Reference: 1150006BSS
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

Test rapide COVID-19 COVI'LAB

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 03664965001037
Basic UDI-DI: B-03664965001037
Reference: INCP-502H
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.07.2026 17:41

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX COMBO COVID-FLU-RSV BSS

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678600222
Basic UDI-DI: B-03532678600222
Reference: SW40011
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:47

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX DENGUE Ab BSS

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678592985
Basic UDI-DI: B-03532678592985
Reference: SW40016
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX DENGUE Ag BSS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678592978
Basic UDI-DI: B-03532678592978
Reference: SW40015
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX DENGUE COMBO BSS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678592961
Basic UDI-DI: B-03532678592961
Reference: SW40014
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details