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MutaREAL® HFE

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002821
Basic UDI-DI: B-04050598002821
Reference: KF291096
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

Hemoglobin (A2/F/A1c) Calibrator Kit

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384631043
Basic UDI-DI: B-06938384631043
Reference: L-500309
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

MutaREAL® Cystic Fibrosis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010833
Basic UDI-DI: B-04050598010833
Reference: KF290832
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

MutaREAL® Cystic Fibrosis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010826
Basic UDI-DI: B-04050598010826
Reference: KF290896
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598015227
Basic UDI-DI: B-04050598015227
Reference: KSTDE001GP5.02
EMDN: W0105060399
EMDN description: MYCOLOGY IMMUNOASSAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

Lysozym ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000445
Basic UDI-DI: B-04050598000445
Reference: K 6901
EMDN: W01010124
EMDN description: LYSOZYME
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

MutaREAL® TPMT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598001688
Basic UDI-DI: B-04050598001688
Reference: KF291332
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598015234
Basic UDI-DI: B-04050598015234
Reference: KSTDE001GP5.03
EMDN: W0105060399
EMDN description: MYCOLOGY IMMUNOASSAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

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: 06938384631401
Basic UDI-DI: B-06938384631401
Reference: L-560204
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

MutaREAL® TPMT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598001695
Basic UDI-DI: B-04050598001695
Reference: KF291396
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

MutaREAL® MTHFR C677T

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010062
Basic UDI-DI: B-04050598010062
Reference: KF291432-A
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

MutaREAL® MTHFR C677T

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003187
Basic UDI-DI: B-04050598003187
Reference: KF291496-A
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

MutaREAL® MTHFR A1298C

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598008793
Basic UDI-DI: B-04050598008793
Reference: KF291432-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

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