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Protein Induced by Vitamin K Absence or Antagonist-Ⅱ (PIVKAⅡ) Assay Kit(Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502606
Basic UDI-DI: B-06942028502606
Reference: DD2101
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

MutaREAL® MTHFR A1298C

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003194
Basic UDI-DI: B-04050598003194
Reference: KF291496-B
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:02

Manufacturer products View details

Hemoglobin (A2/F/A1c) Test Reagent Kit (HPLC)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384631418
Basic UDI-DI: B-06938384631418
Reference: L-560205
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

IDKmagnetics® Vitamin D duo LC-MS/MS kit

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598007864
Basic UDI-DI: B-04050598007864
Reference: KM1311
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:02

Manufacturer products View details

MutaREAL® COMT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002890
Basic UDI-DI: B-04050598002890
Reference: KF291596
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:02

Manufacturer products View details

Interleukin -4 (IL-4) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501265
Basic UDI-DI: B-06942028501265
Reference: DC1701
EMDN: W01030606
EMDN description: OTHER INTERLEUKINS (EXCEPT FOR IL-6)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

MutaREAL® Faktor II

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002913
Basic UDI-DI: B-04050598002913
Reference: KF291632
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:02

Manufacturer products View details

MutaREAL® Faktor II

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003118
Basic UDI-DI: B-04050598003118
Reference: KF291696
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:02

Manufacturer products View details

MutaREAL® Factor V

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002920
Basic UDI-DI: B-04050598002920
Reference: KF291732
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:01

Manufacturer products View details

MutaREAL® Faktor V

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003125
Basic UDI-DI: B-04050598003125
Reference: KF291796
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:01

Manufacturer products View details

MutaREAL® UGT1A1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003569
Basic UDI-DI: B-04050598003569
Reference: KF291896
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:01

Manufacturer products View details

MutaREAL® PAI-1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002869
Basic UDI-DI: B-04050598002869
Reference: KF291932
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:01

Manufacturer products View details

Interferon Alpha (IFNα) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501104
Basic UDI-DI: B-06942028501104
Reference: DC1301
EMDN: W01030601
EMDN description: INTERFERONS (α, β, ɣ…)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

IDK® PMN-Elastase ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000490
Basic UDI-DI: B-04050598000490
Reference: K 6830
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:01

Manufacturer products View details

PreventID® C. diff Combo Tox A + B

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013452
Basic UDI-DI: B-04050598013452
Reference: KSTICDT625G10
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:00

Manufacturer products View details

Lysozym ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000452
Basic UDI-DI: B-04050598000452
Reference: K 6902
EMDN: W01010124
EMDN description: LYSOZYME
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:00

Manufacturer products View details

PreventID® C. diff Combo Tox A + B

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013469
Basic UDI-DI: B-04050598013469
Reference: KSTICDT625GP
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 14:59

Manufacturer products View details

Interferon Gamma (IFNγ) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501302
Basic UDI-DI: B-06942028501302
Reference: DC1801
EMDN: W01030601
EMDN description: INTERFERONS (α, β, ɣ…)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

Prostatype® RT qPCR Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Prostatype Genomics AB
Manufacturer SRN: SE-MF-000013349
UDI-DI: 07350086460094
Basic UDI-DI: 735008646PG000526
Reference: PG0009
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 24.09.2026 14:54

Manufacturer products View details

Bone Gla Protein (BGP) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502408
Basic UDI-DI: B-06942028502408
Reference: DH0201
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details