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SARS-CoV-2 (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: 07350123504705
Basic UDI-DI: B-07350123504705
Reference: ICOV-803H
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal pH Rapid Test Panel

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 07350123504606
Basic UDI-DI: B-07350123504606
Reference: IVPH-504H
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

Urinary Tract Infections Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 07350123504576
Basic UDI-DI: B-07350123504576
Reference: U031-04H
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D 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: 07350123504545
Basic UDI-DI: B-07350123504545
Reference: OVD-402H
EMDN: W0103030901
EMDN description: COMBINED ABO TYPING + RHESUS D
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

TSH 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: 07350123504514
Basic UDI-DI: B-07350123504514
Reference: OTS-402H
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin 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: 07350123504484
Basic UDI-DI: B-07350123504484
Reference: OFE-402H
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

VB12 test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598232897
Basic UDI-DI: B-06942598232897
Reference: FI-VB12-302
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 06.07.2026 11:30

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598232880
Basic UDI-DI: B-06942598232880
Reference: FI-VD-402
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:30

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598232507
Basic UDI-DI: B-06942598232507
Reference: FI-HBA-402
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598232361
Basic UDI-DI: B-06942598232361
Reference: FI-FER-402
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

TSH Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598232316
Basic UDI-DI: B-06942598232316
Reference: FI-TSH-402
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

High-Sensitivity NT-proBNP Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598232064
Basic UDI-DI: B-06942598232064
Reference: FI-SNBNP-402
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

High-Sensitivity Cardiac Troponin I Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598232033
Basic UDI-DI: B-06942598232033
Reference: FI-SCTI-402
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598231913
Basic UDI-DI: B-06942598231913
Reference: FI-CRP-402
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598223765
Basic UDI-DI: B-06942598223765
Reference: AFR-900
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

ToRCH IgM Combo Rapid Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598205358
Basic UDI-DI: B-06942598205358
Reference: ITOM-345
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

Toxo IgG/IgM Rapid Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598205341
Basic UDI-DI: B-06942598205341
Reference: ITGM-302
EMDN: W0105050199
EMDN description: TOXOPLASMA REAGENTS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

HCV Rapid Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-06936983106009W4
Basic UDI-DI: B-06936983106009W4
Reference: IHC-402
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 12 Drugs Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126472
Basic UDI-DI: B-06936983126472
Reference: DOA-1125
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

Prueba de infecciones del tracto urinario

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126298
Basic UDI-DI: B-06936983126298
Reference: U031-10
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details