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Monkeypox Virus Antigen Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-MXG-402VD
Basic UDI-DI: B-ACO-MXG-402VD
Reference: ACO-MXG-402
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-NOV-602XQ
Basic UDI-DI: B-ACO-NOV-602XQ
Reference: ACO-NOV-602
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Greece
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

HPIV Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-HPIV-5024F
Basic UDI-DI: B-ACO-HPIV-5024F
Reference: ACO-HPIV-502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

HMPV Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-HMPV-5025P
Basic UDI-DI: B-ACO-HMPV-5025P
Reference: ACO-HMPV-502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG, IgM and NS1 Combo Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-DEC-435FY
Basic UDI-DI: B-ACO-DEC-435FY
Reference: ACO-DEC-435
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

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Adenovirus pneumoniae and RSV Combo Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-AR-502LG
Basic UDI-DI: B-ACO-AR-502LG
Reference: ACO-AR-502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Cyprus
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

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Adenovirus pneumoniae Antigen Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-AD-502FN
Basic UDI-DI: B-ACO-AD-502FN
Reference: ACO-AD-502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Croatia
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Influenza A&B qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717387
Basic UDI-DI: B-08683079717387
Reference: IP202220-500
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:22

Manufacturer products View details

RevoDx Influenza A&B qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717370
Basic UDI-DI: B-08683079717370
Reference: IP202220-100
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:22

Manufacturer products View details

Influenza A+B Rapid Test Cassette

Influenza A+B Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277515269
Basic UDI-DI: B-06970277515269
Reference: IIN-R502
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

MONO Rapid Test Cassette

MONO Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277513289
Basic UDI-DI: B-06970277513289
Reference: IMO-402
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277511063
Basic UDI-DI: B-06970277511063
Reference: IIN-502
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

HCG Pregnancy Test (Colloidal Gold)

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062777823
Basic UDI-DI: B-06952062777823
Reference: HCG3UST-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

COVID-19 (SARS-CoV-2) Antigen Test Kit

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062774235
Basic UDI-DI: B-06952062774235
Reference: SL030101NST-X
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)- Saliva

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062774112
Basic UDI-DI: B-06952062774112
Reference: SL030101SST-X
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit- Saliva

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062772835
Basic UDI-DI: B-06952062772835
Reference: SL030101SST-X
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Croatia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (Sars-CoV-2) Antigen Test Midstream - Saliva

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062772781
Basic UDI-DI: B-06952062772781
Reference: COVAg3SST-X
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)- Saliva

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062772774
Basic UDI-DI: B-06952062772774
Reference: SL030101SST-X
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)- Saliva

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062772767
Basic UDI-DI: B-06952062772767
Reference: SL030101SST-X
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062772750
Basic UDI-DI: B-06952062772750
Reference: SL030101NST-X
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details