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POC SARS-CoV-2 Nucleic Acid Detection Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: D-RA010UC
Basic UDI-DI: B-RA010UC
Reference: P122-05024
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

CerTest Adenovirus

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440201441
Basic UDI-DI: 84354402IDXGASTROB_AD5W
Reference: AD820001VC
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: -
Last updated: 14.07.2026 22:50

Manufacturer products View details

CerTest Adenovirus

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440207320
Basic UDI-DI: 84354402IDXGASTROB_AD5W
Reference: AD820001VCC
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: -
Last updated: 14.07.2026 22:50

Manufacturer products View details

D-OF02-COV6F

SARS-CoV-2 Ag Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: D-OF02-COV6F
Basic UDI-DI: B-OF02-COV6F
Reference: OF02-COV
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-NOV-F02aQ5
Basic UDI-DI: B-NOV-F02aQ5
Reference: NOV-F02a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90507ZK

Influenza A&B Antigen Test kit(Colloidal Gold Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90507ZK
Basic UDI-DI: B-K90507ZK
Reference: /
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

50 tests/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD53-02-50tBT
Basic UDI-DI: B-IVD53-02-50tBT
Reference: IVD53-02-50t
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

20 tests/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD53-02-20tBC
Basic UDI-DI: B-IVD53-02-20tBC
Reference: IVD53-02-20t
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

1 test/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD53-02-1tH5
Basic UDI-DI: B-IVD53-02-1tH5
Reference: IVD53-02-1t
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

10 tests/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD53-02-10tB7
Basic UDI-DI: B-IVD53-02-10tB7
Reference: IVD53-02-10t
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ISCOVu005G
Basic UDI-DI: B-ISCOVu005G
Reference: ISCOVu002-A001; ISCOVu002-A005; ISCOVu002-A025; ISCOVu002-B001; ISCOVu002-B005; ISCOVu002-B025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Hungary
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMXG-R402HE
Basic UDI-DI: B-IMXG-R402HE
Reference: IMXG-R402
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMXB-R402FD
Basic UDI-DI: B-IMXB-R402FD
Reference: IMXB-R402
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-IIN-501SC

IIN-501

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-IIN-501SC
Basic UDI-DI: B-IIN-501SC
Reference: IIN-501
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue/Zika/Chikungunya 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-IDZC-R445C3
Basic UDI-DI: B-IDZC-R445C3
Reference: IDZC-R445
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue 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-IDEC-R425YM
Basic UDI-DI: B-IDEC-R425YM
Reference: IDEC-R425
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue/Chikungunya/Zika 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-IDCZ-R43594
Basic UDI-DI: B-IDCZ-R43594
Reference: IDCZ-R435
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test

cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOV05FD
Basic UDI-DI: B-ICOV05FD
Reference: ICOV5002-B001;ICOV5002-B005;ICOV5002-B025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Cryptosporidium and Giardia lamblia 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-ICGC-R625ZE
Basic UDI-DI: B-ICGC-R625ZE
Reference: ICGC-R625
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:04

Manufacturer products Authorised representative products Authorised representative actors View details

HSV IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HSV-D02aN9
Basic UDI-DI: B-HSV-D02aN9
Reference: HSV-D02a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details