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Intact Parathormone Detection Kit (Chemiluminescence Immunoassay)

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223860
Basic UDI-DI: B-06942202223860
Reference: 3013920
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:50

Manufacturer products Authorised representative products Authorised representative actors View details

Calcitonin Detection Kit (Chemiluminescence Immunoassay)

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223853
Basic UDI-DI: B-06942202223853
Reference: 3013888
EMDN: W0102060301
EMDN description: CALCITONIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:50

Manufacturer products Authorised representative products Authorised representative actors View details

25-Hydroxyvitamin D Detection Kit (Chemiluminescence Immunoassay)

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223846
Basic UDI-DI: B-06942202223846
Reference: 3013918
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:50

Manufacturer products Authorised representative products Authorised representative actors View details

Bone Glaprotein Detection Kit (Chemiluminescence Immunoassay)

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223839
Basic UDI-DI: B-06942202223839
Reference: 3013884
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:50

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamine D Sneltest Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983167659
Basic UDI-DI: B-06936983167659
Reference: OVD-402H
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Netherlands
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin-D-Schnelltestkassette

Vitamin D Rapid Test Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983129459
Basic UDI-DI: B-06936983129459
Reference: OVD-402H
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Rapid Test Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983125826
Basic UDI-DI: B-06936983125826
Reference: OVD-402H
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

06936983119207

Vitamin D Rapid Test Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983119207
Basic UDI-DI: B-06936983119207
Reference: OVD-402H
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Lithuania
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Rapid Test Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983100984
Basic UDI-DI: B-06936983100984
Reference: OVD-402H
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020115

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020115
Basic UDI-DI: B-06936791020115
Reference: JG0301-25
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

Neutrophil gelatinase-associated lipocalin Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009442
Basic UDI-DI: B-06934175009442
Reference: 12600551
EMDN: W0102060207
EMDN description: NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214426
Basic UDI-DI: B-06933260214426
Reference: BT2501-HBA1C
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214297
Basic UDI-DI: B-06933260214297
Reference: BT2501-HBA1C
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802360

200 tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802360
Basic UDI-DI: B-06930317802360
Reference: DNK-1901-31
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802353

100 tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802353
Basic UDI-DI: B-06930317802353
Reference: DNK-1901-31
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:37

Manufacturer products Authorised representative products Authorised representative actors View details

Neutrophil Gelatinase-associated Lipocalin Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x30mL, R2: 1x10mL, Calibration sample: 5x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593818
Basic UDI-DI: B-06925794593818
Reference: 3021560
EMDN: W0102060207
EMDN description: NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Neutrophil Gelatinase-associated Lipocalin Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x30mL, R2: 1x10mL，

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593801
Basic UDI-DI: B-06925794593801
Reference: 3021622
EMDN: W0102060207
EMDN description: NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x30mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794592712
Basic UDI-DI: B-06925794592712
Reference: 3021722
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:47

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x30mL, R2: 1x10mL,Calibration sample: 5x1mL, Control: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794592705
Basic UDI-DI: B-06925794592705
Reference: 3021661
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:47

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin Detection Kit (Chemiluminescence Immunoassay)

1×50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794520357
Basic UDI-DI: B-06925794520357
Reference: 3013877
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:36

Manufacturer products Authorised representative products Authorised representative actors View details