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COVID-19 Nucleocapsid Protein IgG Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICNG-402CR
Basic UDI-DI: B-ICNG-402CR
Reference: ICNG-402
EMDN: W0105041103
EMDN description: CORONAVIRUS IGG
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
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

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM 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-NCP-402SP
Basic UDI-DI: B-FI-NCP-402SP
Reference: FI-NCP-402
EMDN: W0105041102
EMDN description: CORONAVIRUS ANTIBODIES - TOTAL
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:20

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COVID-19 S-RBD IgG Antibody 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-CSG-402Q9
Basic UDI-DI: B-FI-CSG-402Q9
Reference: FI-CSG-402
EMDN: W0105041103
EMDN description: CORONAVIRUS IGG
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:20

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Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849369809
Basic UDI-DI: 697484936W0105900101HP
Reference: HWTS-3019-24
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.07.2026 09:17

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Jiangsu Macro & Micro-Test Med-Tech Co., Ltd

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849369816
Basic UDI-DI: 697484936W0105900101HP
Reference: HWTS-3019-162
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.07.2026 09:17

Manufacturer products Authorised representative products Authorised representative actors View details

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849369823
Basic UDI-DI: 697484936W0105900101HP
Reference: HWTS-3019-242
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.07.2026 09:17

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit