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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® Dengue NS1 Antigen Cassette (Whole Blood/Serum/Plasma)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432290
Basic UDI-DI: B-06970581432290
Reference: ABT-IDT-B216
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
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® Dengue IgG/IgM/NS1 Combo Cassette (Whole Blood/Serum/Plasma)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432283
Basic UDI-DI: B-06970581432283
Reference: ABT-IDT-B217
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
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® Dengue 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: 06970581432276
Basic UDI-DI: B-06970581432276
Reference: ABT-IDT-B97
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
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® Influenza A+B Cassette (Swab/Nasal Aspirate)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432269
Basic UDI-DI: B-06970581432269
Reference: ABT-IDT-B247
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
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® RSV Antigen Cassette (Swab)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432252
Basic UDI-DI: B-06970581432252
Reference: ABT-IDT-B296
EMDN: W0105099002
EMDN description: RSV - RT & POC
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

Influenza A&B Antigen Rapid Test (Colloidal Gold)

VILFA-20

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN: CN-MF-000027997
UDI-DI: 06970514080963
Basic UDI-DI: B-06970514080963
Reference: VILFA-20
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 30.06.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Antigen Rapid Test (Colloidal Gold)

VILFA-01

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN: CN-MF-000027997
UDI-DI: 06970514080956
Basic UDI-DI: B-06970514080956
Reference: VILFA-01
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 30.06.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277518277
Basic UDI-DI: B-06970277518277
Reference: ICOV-802H
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277515719
Basic UDI-DI: B-06970277515719
Reference: ICOV-502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.06.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

06970277513340

Norovirus/Rotavirus/Adenovirus Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277513340
Basic UDI-DI: B-06970277513340
Reference: INRA-635
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus Rapid Test Cassette (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277513302
Basic UDI-DI: B-06970277513302
Reference: INO-602
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Influenza A+B/RSV/Adenovirus Ag Combo Rapid Test

VISIRA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221768963
Basic UDI-DI: B-06970221768963
Reference: VISIRA-757
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 29.06.2026 23:36

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test

VISIR

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221768956
Basic UDI-DI: B-06970221768956
Reference: VISIR-737
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 29.06.2026 23:36

Manufacturer products Authorised representative products Authorised representative actors View details