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SARS-CoV-2/Influenza A+B/RSV/ Adenovirus/ M.pneumoniae Antigen Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRT-555(AT)RX
Basic UDI-DI: B-IRT-555(AT)RX
Reference: IRT-555
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Influenza A+B/RSV/ Adenovirus Antigen Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRT-545(AT)RJ
Basic UDI-DI: B-IRT-545(AT)RJ
Reference: IRT-545
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Syncytial Virus RT-qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRS-P50(AT)5E
Basic UDI-DI: B-IRS-P50(AT)5E
Reference: IRS-P50
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRO-607(AT)MJ
Basic UDI-DI: B-IRO-607(AT)MJ
Reference: IRO-607
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Group A and Norovirus GI/GII RT-qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRN-P61(AT)2K
Basic UDI-DI: B-IRN-P61(AT)2K
Reference: IRN-P61
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Reagent - Lyse

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180892
Basic UDI-DI: 697657818032060072W
Reference: 0320900125
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220838
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3023668
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Reagent - Lyse

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180885
Basic UDI-DI: 697657818032060072W
Reference: 0320900126
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220845
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3024017
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

TESTA med® SCHWANGERSCHAFTS-FRÜHTESTTESTA med® SCHWANGERSCHAFTS-FRÜHTEST

IVD Class BIVDR 2017/746On the marketKitNear-patient testingSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725814845
Basic UDI-DI: 697072581B1HCG00N25S11CRP
Reference: HCG 114-2
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220852
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3023669
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

TESTA med® SCHWANGERSCHAFTS-FRÜHTEST

IVD Class BIVDR 2017/746On the marketKitNear-patient testingSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725814869
Basic UDI-DI: 697072581B1HCG00N25S11CRP
Reference: HCG 112
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Group A and Norovirus GI/GII RT-qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRN-P60(AT)28
Basic UDI-DI: B-IRN-P60(AT)28
Reference: IRN-P60
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Rhinovirus Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRHV-502(AT)2X
Basic UDI-DI: B-IRHV-502(AT)2X
Reference: IRHV-502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

HPIV Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IPIV-502(AT)ZT
Basic UDI-DI: B-IPIV-502(AT)ZT
Reference: IPIV-502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus/Rotavirus/Adenovirus Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-INRA-RT635(AT)3L
Basic UDI-DI: B-INRA-RT635(AT)3L
Reference: INRA-RT635
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus/Rotavirus/Adenovirus Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-INRA-637(AT)UE
Basic UDI-DI: B-INRA-637(AT)UE
Reference: INRA-637
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-INO-607(AT)HW
Basic UDI-DI: B-INO-607(AT)HW
Reference: INO-607
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMXG-402(AT)Z7
Basic UDI-DI: B-IMXG-402(AT)Z7
Reference: IMXG-402
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antibody Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMXB-402(AT)VL
Basic UDI-DI: B-IMXB-402(AT)VL
Reference: IMXB-402
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details