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EUDAMED Device Search

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730 device results listed.

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COVID-19 Ab Rapid Test Kit（WB/Serum/Plasma）

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751386
Basic UDI-DI: B-06970664751386
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

COVID-19 Ab Test Kit（ELISA）

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751379
Basic UDI-DI: B-06970664751379
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

COVID-19 Antigen ELISA Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751362
Basic UDI-DI: B-06970664751362
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

COVID-19 IgM Antibody ELISA Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751355
Basic UDI-DI: B-06970664751355
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

COVID-19 IgG Antibody ELISA Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751348
Basic UDI-DI: B-06970664751348
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

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: 06970664751331
Basic UDI-DI: B-06970664751331
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

COVID-19 IgG/IgM 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: 06970664751324
Basic UDI-DI: B-06970664751324
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

COVID-19 IgG/IgM Ab 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: 06970664750921
Basic UDI-DI: B-06970664750921
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

Multiple Real-Time PCR kit for Detection 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: 06970664750396
Basic UDI-DI: B-06970664750396
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 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Human Monkeypox virus Cassette (Lesion exudate swab)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432375
Basic UDI-DI: B-06970581432375
Reference: ABT-IDT-B401
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:49

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Human Monkeypox virus Antibody Cassette (Whole Blood/Serum/Plasma)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432368
Basic UDI-DI: B-06970581432368
Reference: ABT-IDT-B399
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:49

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® COVID-19 Antigen Cassette (Nasal Swab)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432337
Basic UDI-DI: B-06970581432337
Reference: ABT-IDT-B374
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:49

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® COVID-19 Antigen Cassette (Saliva)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432320
Basic UDI-DI: B-06970581432320
Reference: ABT-IDT-B372
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:49

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432313
Basic UDI-DI: B-06970581432313
Reference: ABT-IDT-B373
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:49

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody Cassette (Whole Blood/Serum/Plasma)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432306
Basic UDI-DI: B-06970581432306
Reference: ABT-IDT-B371
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:49

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® SARS-CoV-2+Flu A&B Antigen Combo Cassette (Nasopharyngeal Swab)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432146
Basic UDI-DI: B-06970581432146
Reference: ABT-IDT-B370
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:49

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Rotavirus Cassette (Feces)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430494
Basic UDI-DI: B-06970581430494
Reference: ABT-IDT-B63
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Rotavirus/Adenovirus Combo Cassette(Feces)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430203
Basic UDI-DI: B-06970581430203
Reference: ABT-IDT-B64
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® SARS-CoV-2 (Nasopharyngeal Swab)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430043
Basic UDI-DI: B-06970581430043
Reference: ABT-IDT-B367
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:41

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® COVID-19 IgG/IgM Cassette (Whole Blood/ Serum/ Plasma)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430036
Basic UDI-DI: B-06970581430036
Reference: ABT-IDT-B352
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:41

Manufacturer products Authorised representative products Authorised representative actors View details