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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

Malaria P.f. /P.v. Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMPV-R402K9
Basic UDI-DI: B-IMPV-R402K9
Reference: IMPV-R402
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - 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-IMPN-401M8

Malaria P.f./Pan Rapid Test Dipstick

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMPN-401M8
Basic UDI-DI: B-IMPN-401M8
Reference: IMPN-401
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:39

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Malaria P.f./Pan Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMPN-R402FZ
Basic UDI-DI: B-IMPN-R402FZ
Reference: IMPN-R402
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - 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

Malaria P.f. Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMA-R402C3
Basic UDI-DI: B-IMA-R402C3
Reference: Alltest
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Croatia
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:38

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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

D-IHP-402SJ

IHP-402

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-IHP-402SJ
Basic UDI-DI: B-IHP-402SJ
Reference: IHP-402
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:09

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RightSign

IHIV-C42

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: HangZhou Biotest Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000008191
UDI-DI: D-IHIV-C42M4
Basic UDI-DI: B-IHIV-C42M4
Reference: IHIV-C42
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:09

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RightSign

IHCV-C31

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: HangZhou Biotest Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000008191
UDI-DI: D-IHCV-C31JH
Basic UDI-DI: B-IHCV-C31JH
Reference: IHCV-C31
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:09

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RightSign

IHBSG-C31

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: HangZhou Biotest Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000008191
UDI-DI: D-IHBSG-C31AR
Basic UDI-DI: B-IHBSG-C31AR
Reference: IHBSG-C31
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-IGV-502UC

Gardnerella vaginalis Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IGV-502UC
Basic UDI-DI: B-IGV-502UC
Reference: IGV-502
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

Filariasis 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-IFIL-R4027B
Basic UDI-DI: B-IFIL-R4027B
Reference: IFIL-R402
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

Entamoeba+Giardia+Crypto Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IEGC-R6372W
Basic UDI-DI: B-IEGC-R6372W
Reference: IEGC-R637
EMDN: W0105090499
EMDN description: PARASITES - 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

Entamoeba+Giardia+Crypto 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-IEGC-R6352S
Basic UDI-DI: B-IEGC-R6352S
Reference: IEGC-R635
EMDN: W0105090499
EMDN description: PARASITES - 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

Entamoeba/Giardia/Crypto Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IEGC-R6022B
Basic UDI-DI: B-IEGC-R6022B
Reference: IEGC-R602
EMDN: W0105090499
EMDN description: PARASITES - 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/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