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Urea Reagent Kit (Urease-Glutamate Dehydrogenase Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202214547
Basic UDI-DI: 69422022W0101020401R0KM
Reference: 3023461
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
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

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: 06942202220821
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3023735
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

Urea Reagent Kit (Urease-Glutamate Dehydrogenase Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202214561
Basic UDI-DI: 69422022W0101020401R0KM
Reference: 3023424
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
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

Urea Reagent Kit (Urease-Glutamate Dehydrogenase Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202214578
Basic UDI-DI: 69422022W0101020401R0KM
Reference: 3023508
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
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

Urea Reagent Kit (Urease-Glutamate Dehydrogenase Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202214585
Basic UDI-DI: 69422022W0101020401R0KM
Reference: 3023509
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
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

Urea Reagent Kit (Urease-Glutamate Dehydrogenase Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202214592
Basic UDI-DI: 69422022W0101020401R0KM
Reference: 3023484
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
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

Urea Reagent Kit (Urease-Glutamate Dehydrogenase Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202214608
Basic UDI-DI: 69422022W0101020401R0KM
Reference: 3023485
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
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

Urea Reagent Kit (Urease-Glutamate Dehydrogenase Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202214615
Basic UDI-DI: 69422022W0101020401R0KM
Reference: 3023437
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
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

Ferritin (Ferr) Test Kit (Homogeneous Chemiluminescence Immunoassay)

Ferritin(Ferr) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524060649
Basic UDI-DI: B-06974524060649
Reference: HCLIA15133
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Krebs von den Lungen 6 (KL-6) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061561
Basic UDI-DI: B-06974524061561
Reference: HCLIA15132
EMDN: W01030602
EMDN description: SOLUBLE ANTIGENS / RECEPTORS
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Urea Reagent Kit (Urease-Glutamate Dehydrogenase Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202214622
Basic UDI-DI: 69422022W0101020401R0KM
Reference: 3023510
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
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

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

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRTA-555(AT)ZP
Basic UDI-DI: B-IRTA-555(AT)ZP
Reference: IRTA-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

Free Thyroxine (FT4) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061660
Basic UDI-DI: B-06974524061660
Reference: HCLIA15109
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c (HbA1c) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061684
Basic UDI-DI: B-06974524061684
Reference: HCLIA15105
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: HUMISS TRADING 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: 06976578180922
Basic UDI-DI: 697657818032060072W
Reference: 0320900123
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

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

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRTA-545(AT)ZA
Basic UDI-DI: B-IRTA-545(AT)ZA
Reference: IRTA-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

Hematology Reagent - Lyse

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180946
Basic UDI-DI: 697657818032060072W
Reference: 0320900124
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

Multiplex Respiratory Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRT9-555(AT)UN
Basic UDI-DI: B-IRT9-555(AT)UN
Reference: IRT9-555
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/ 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