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06974167892164

123145-01-102 123145-02-102 123145-05-102 123145-20-102

IVD Class CIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892164
Basic UDI-DI: 697416789123145ZT
Reference: 123145-05-102
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Safety summary (SSCP/SSP): 2 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 30.06.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

06974167892157

123145-01-102 123145-02-102 123145-05-102 123145-20-102

IVD Class CIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892157
Basic UDI-DI: 697416789123145ZT
Reference: 123145-02-102
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Safety summary (SSCP/SSP): 2 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 30.06.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

06974167892140

123145-01-102 123145-02-102 123145-05-102 123145-20-102

IVD Class CIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892140
Basic UDI-DI: 697416789123145ZT
Reference: 123145-01-102
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Safety summary (SSCP/SSP): 2 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 30.06.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

5in1VIRENTEST , SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)

123143-01-102 123143-02-102 123143-05-102 123143-20-102

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167891655
Basic UDI-DI: 697416789100NQ
Reference: 123143-01-102
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): 1 · Rev. 1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 30.06.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

06970895474238

FLU A&B &COVID-19 & RSV & Adeno Antigen Combo Test Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895474238
Basic UDI-DI: B-06970895474238
Reference: R224T020B0C0
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Lithuania
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

06970895474221

SARS-CoV-2 & FLU A&B & RSV Antigen Combo Test Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895474221
Basic UDI-DI: B-06970895474221
Reference: R223T020B0C0
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Czechia
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

06970664755704

COVID-19 Antigen Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664755704
Basic UDI-DI: B-06970664755704
Reference: 5Tests/Kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

06970664755414

COVID-19 Antigen Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664755414
Basic UDI-DI: B-06970664755414
Reference: 1Test/Kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

06970664755315

COVID-19 Antigen Rapid Test Kit（Oral Saliva）

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664755315
Basic UDI-DI: B-06970664755315
Reference: 5Tests/Kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

06970664755216

COVID-19 Antigen Rapid Test Kit（Oral Saliva）

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664755216
Basic UDI-DI: B-06970664755216
Reference: 1Test/Kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

06970664755018

COVID-19 Antigen Rapid Test Kit（Oral Saliva）

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664755018
Basic UDI-DI: B-06970664755018
Reference: 25Tests/Kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

06970664754615

COVID-19 Antigen Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664754615
Basic UDI-DI: B-06970664754615
Reference: 25Tests/Kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

06970664752406

Multiple Rapid Real-Time PCR kit for Detection of A E gene and Omicron mutation of SARS-CoV-2

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664752406
Basic UDI-DI: B-06970664752406
Reference: 48Tests/kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

06970664752376

COVID-19 Antigen Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664752376
Basic UDI-DI: B-06970664752376
Reference: 7Tests/KIt
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

06970664751577

COVID-19 Antigen Rapid Test Kit

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testing

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751577
Basic UDI-DI: B-06970664751577
Reference: 5 Tests/kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

06970664751515

COVID-19 Neutralization Antibody Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751515
Basic UDI-DI: B-06970664751515
Reference: 25Tests/kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

06970664751492

COVID-19 Neutralization Antibody Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751492
Basic UDI-DI: B-06970664751492
Reference: 25Tests/kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

06970664751485

COVID-19 Neutralization Antibody ELISA Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751485
Basic UDI-DI: B-06970664751485
Reference: 96Tests/kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

06970664751478

SARS-COV-2/FIuA/FIuB Antigen Combo Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751478
Basic UDI-DI: B-06970664751478
Reference: 25Tests/kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

06970664751393

COVID-19 nucleic acid Test kit (fluorescence PCR)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751393
Basic UDI-DI: B-06970664751393
Reference: 50Tests/Kit
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details