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06941571802317

R102-114

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571802317
Basic UDI-DI: B-06941571802317
Reference: R102-114
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test Cassette

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983188753
Basic UDI-DI: B-06936983188753
Reference: IHP-R402
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983188661
Basic UDI-DI: B-06936983188661
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983167628
Basic UDI-DI: B-06936983167628
Reference: IDES-402
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983167543
Basic UDI-DI: B-06936983167543
Reference: ISY-402
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 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: 06936983167055
Basic UDI-DI: B-06936983167055
Reference: INCP-502H
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

Cassette Test Rapide Strep A

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983164788
Basic UDI-DI: B-06936983164788
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antigen Rapid Test Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983152662
Basic UDI-DI: B-06936983152662
Reference: IHP-602H
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antibody Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983148825
Basic UDI-DI: B-06936983148825
Reference: FI-MXB-402
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983148818
Basic UDI-DI: B-06936983148818
Reference: FI-MXG-402
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983148801
Basic UDI-DI: B-06936983148801
Reference: ICOV-501
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

06936983139236

SARS-CoV-2 Antigen Rapid Test

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983139236
Basic UDI-DI: B-06936983139236
Reference: INCP-502H
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983134873
Basic UDI-DI: B-06936983134873
Reference: IMXB-402
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

06936983134613

Strep A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983134613
Basic UDI-DI: B-06936983134613
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Lithuania
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126229
Basic UDI-DI: B-06936983126229
Reference: ISY-402
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126175
Basic UDI-DI: B-06936983126175
Reference: ICD-635
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

Prueba Rápida de S. pneumoniae Antígeno en Casete

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126168
Basic UDI-DI: B-06936983126168
Reference: ISP-102
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Iceland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

Gonorrhea Rapid Test

W0105090199

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126052
Basic UDI-DI: B-06936983126052
Reference: IGO-502
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

HBsAg Rapid Test Cassette

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983122986
Basic UDI-DI: B-06936983122986
Reference: IHBSG-402
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

HBsAg Rapid Test Cassette

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983122955
Basic UDI-DI: B-06936983122955
Reference: IHBSG-402
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details