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Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Tongzhou Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000038774
UDI-DI: D-I171-5055ZK
Basic UDI-DI: B-I171-5055ZK
Reference: I171-5055
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Infectious Diseases Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-I(Analytes)-ACO5X7CP
Basic UDI-DI: B-I(Analytes)-ACO5X7CP
Reference: I(Analytes)-ACO5X7
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-HydradynLM

Hydradyn

Class IIIMDDOn the marketImplantableSingle useSterile

Manufacturer: I.R.A. Istituto Ricerche Applicate S.p.A.
Manufacturer SRN: IT-MF-000009981
UDI-DI: D-HydradynLM
Basic UDI-DI: B-HydradynLM
Reference: 40257
EMDN: P900402
EMDN description: RESORBABLE FILLING AND RECONSTRUCTION DEVICES
First on market country: Italy
Authorised representative: -
Last updated: 13.10.2026 11:10

Manufacturer products View details

D-HarzatiLinear40391M9

Harzati Linear

Class IIIMDDOn the marketImplantableSingle useSterile

Manufacturer: I.R.A. Istituto Ricerche Applicate S.p.A.
Manufacturer SRN: IT-MF-000009981
UDI-DI: D-HarzatiLinear40391M9
Basic UDI-DI: B-HarzatiLinear40391M9
Reference: 40391
EMDN: P900402
EMDN description: RESORBABLE FILLING AND RECONSTRUCTION DEVICES
First on market country: Italy
Authorised representative: -
Last updated: 13.10.2026 11:10

Manufacturer products View details

D-HarzatiLinear40392MB

Harzati Linear+

Class IIIMDDOn the marketImplantableSingle useSterile

Manufacturer: I.R.A. Istituto Ricerche Applicate S.p.A.
Manufacturer SRN: IT-MF-000009981
UDI-DI: D-HarzatiLinear40392MB
Basic UDI-DI: B-HarzatiLinear40392MB
Reference: 40392
EMDN: P900402
EMDN description: RESORBABLE FILLING AND RECONSTRUCTION DEVICES
First on market country: Italy
Authorised representative: -
Last updated: 13.10.2026 11:10

Manufacturer products View details

Multi-Drug Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: D-HX5-MDTX6
Basic UDI-DI: B-HX5-MDTX6
Reference: HX5-MDT
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

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H&W tulehduspikatesti CRP

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-HW-800034-1XP
Basic UDI-DI: B-HW-800034-1XP
Reference: HW-800034-1
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Finland
Authorised representative: QbD RepS BV
Last updated: 13.10.2026 11:10

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Hantavirus IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-HVGM-2-DMX
Basic UDI-DI: B-HVGM-2-DMX
Reference: HVGM-2-D
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

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DualDur

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Lyme Diagnostics Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000059441
UDI-DI: D-HU/CA01/8457/206H
Basic UDI-DI: B-HU/CA01/8457/206H
Reference: DD
EMDN: W050101010101
EMDN description: BLOOD COLLECTION, CLOSED SYRINGES WITH ADDITIVES
First on market country: Hungary
Authorised representative: -
Last updated: 13.10.2026 11:10

Manufacturer products View details

Bózsik Western blot

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Lyme Diagnostics Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000059441
UDI-DI: D-HU/CA01/49607/20C7
Basic UDI-DI: B-HU/CA01/49607/20C7
Reference: BWB
EMDN: W0105010699
EMDN description: LYME BORRELIOSIS REAGENTS - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 13.10.2026 11:10

Manufacturer products View details

Triglycerides Test Strips

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-HTG-411(AT)DW
Basic UDI-DI: B-HTG-411(AT)DW
Reference: HTG-411
EMDN: W0101060105
EMDN description: TRIGLYCERIDE TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Triglycerides Test Strips

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-HTG-401(AT)DH
Basic UDI-DI: B-HTG-401(AT)DH
Reference: HTG-401
EMDN: W0101060105
EMDN description: TRIGLYCERIDE TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Total Cholesterol Test Strips

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-HTC-411(AT)B2
Basic UDI-DI: B-HTC-411(AT)B2
Reference: HTC-411
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Total Cholesterol Test Strips

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-HTC-401(AT)AM
Basic UDI-DI: B-HTC-401(AT)AM
Reference: HTC-401
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

HSV 1/2 IgM Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Bi-trumed Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000042268
UDI-DI: D-HSVM-4C1TL
Basic UDI-DI: B-HSVM-4C1TL
Reference: HSVM-4C1
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

HSV 1/2 IgG/IgM Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Bi-trumed Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000042268
UDI-DI: D-HSVGM-4C2PN
Basic UDI-DI: B-HSVGM-4C2PN
Reference: HSVGM-4C2
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

HSV 1/2 IgM Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Bi-trumed Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000042268
UDI-DI: D-HSVM-3C1TF
Basic UDI-DI: B-HSVM-3C1TF
Reference: HSVM-3C1
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

HSV 1/2 IgG/IgM Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Bi-trumed Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000042268
UDI-DI: D-HSVGM-4C1PL
Basic UDI-DI: B-HSVGM-4C1PL
Reference: HSVGM-4C1
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

HSV 1/2 IgG/IgM Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Bi-trumed Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000042268
UDI-DI: D-HSVGM-3C2PH
Basic UDI-DI: B-HSVGM-3C2PH
Reference: HSVGM-3C2
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

HSV 1/2 IgG/IgM Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Bi-trumed Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000042268
UDI-DI: D-HSVGM-3C1PF
Basic UDI-DI: B-HSVGM-3C1PF
Reference: HSVGM-3C1
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details