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Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IMVD-ACO647DE
Basic UDI-DI: B-IMVD-ACO647DE
Reference: IMVD-ACO647
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: France
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IHP-ACO6072J
Basic UDI-DI: B-IHP-ACO6072J
Reference: IHP-ACO607
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Romania
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:29

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Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ICD-ACO637PZ
Basic UDI-DI: B-ICD-ACO637PZ
Reference: ICD-ACO637
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Croatia
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:29

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Campylobacter Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ICAM-ACO607S5
Basic UDI-DI: B-ICAM-ACO607S5
Reference: ICAM-ACO607
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:29

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Astrovirus Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IAS-ACO607X7
Basic UDI-DI: B-IAS-ACO607X7
Reference: IAS-ACO607
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Croatia
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:29

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Adenovirus Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IAD-ACO607NA
Basic UDI-DI: B-IAD-ACO607NA
Reference: IAD-ACO607
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:29

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RSV RapidTest Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRS-502XS
Basic UDI-DI: B-IRS-502XS
Reference: IRS-502
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 06:47

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Influenza A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IFLA-R502(AT)TC
Basic UDI-DI: B-IFLA-R502(AT)TC
Reference: IFLA-R502
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 06:47

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RSV Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-RSV-5025M
Basic UDI-DI: B-FI-RSV-5025M
Reference: FI-RSV-502
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 06:47

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Scrub Typhus IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ITSU-402UM
Basic UDI-DI: B-ITSU-402UM
Reference: ITSU-402
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

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MONO Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMO-R402HR
Basic UDI-DI: B-IMO-R402HR
Reference: IMO-R402
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

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Influenza A/B+H1N1 Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IINA-525EE
Basic UDI-DI: B-IINA-525EE
Reference: IINA-525
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

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Influenza A+B Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IIN-501(AT)A3
Basic UDI-DI: B-IIN-501(AT)A3
Reference: IIN-501
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

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HMPV Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IHMPV-ACO502UU
Basic UDI-DI: B-IHMPV-ACO502UU
Reference: IHMPV-ACO502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IFLA-502BM
Basic UDI-DI: B-IFLA-502BM
Reference: IFLA-502
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IFLA-501BK
Basic UDI-DI: B-IFLA-501BK
Reference: IFLA-501
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Συνδυαστικό τεστ ταχείας ανίχνευσης αντιγόνου του COVID-19 και της Ινφλουέντζας A+B Για αυτοδοκιμή

COVID-19 & Influenza A+B Antigen Combo Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: 06974246461144
Basic UDI-DI: B-06974246461144
Reference: FCO-6032H
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Greece
Authorised representative: Share info GmbH
Last updated: 28.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

S. pneumoniae Antigen Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISP-R102LV
Basic UDI-DI: B-ISP-R102LV
Reference: ISP-R102
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

S. pneumoniae and L. pneumophila Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISLC-R125CV
Basic UDI-DI: B-ISLC-R125CV
Reference: ISLC-R125
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella pneumophila Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ILEG-R10269
Basic UDI-DI: B-ILEG-R10269
Reference: ILEG-R102
EMDN: W0105090108
EMDN description: LEGIONELLA - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details