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Dengue NS1 Antigen Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384621020
Basic UDI-DI: B-06938384621020
Reference: LX-403601
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f (HRP-2) Antigen Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384621037
Basic UDI-DI: B-06938384621037
Reference: LX-403701
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f (HRP-2)/P.v (LDH)/Pan (LDH) Antigen Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622010
Basic UDI-DI: B-06938384622010
Reference: LX-403801
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

PIC 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: 06942028501685
Basic UDI-DI: B-06942028501685
Reference: DG0201
EMDN: W0103020399
EMDN description: SPECIAL COAGULATION TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

PreventID® Entamoeba histolytica

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013483
Basic UDI-DI: B-04050598013483
Reference: KSTIEH602GP
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 14:47

Manufacturer products View details

Human Papillomavirus (HPV) Antigen Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622027
Basic UDI-DI: B-06938384622027
Reference: LX-404101
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

PreventID® H. pylori Antigen

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013506
Basic UDI-DI: B-04050598013506
Reference: KSTIHP602G10
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 14:47

Manufacturer products View details

Treponema Pallidum Antibody Rapid Test kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622034
Basic UDI-DI: B-06938384622034
Reference: LX-404201
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

t-PAIC 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: 06942028501722
Basic UDI-DI: B-06942028501722
Reference: DG0301
EMDN: W0103020507
EMDN description: TISSUE PLASMINOGEN ACTIVATOR
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria Gonorrhoeae Antigen Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622041
Basic UDI-DI: B-06938384622041
Reference: LX-404301
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

Candida Albicans/Trichomonas vaginalis Antigen Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622058
Basic UDI-DI: B-06938384622058
Reference: LX-404401
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio Cholerae O1/O139 Antigen Rapid Test kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622065
Basic UDI-DI: B-06938384622065
Reference: LX-404501
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

Thrombomodulin (TM) 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: 06942028501524
Basic UDI-DI: B-06942028501524
Reference: DG0401
EMDN: W0103020699
EMDN description: COAGULATION INHIBITORS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrin Degradation Products (FDP) 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: 06942028501609
Basic UDI-DI: B-06942028501609
Reference: DG0601
EMDN: W0103020502
EMDN description: FIBRINOGEN DEGRADATION PRODUCTS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

PreTect TM

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: PreTect AS
Manufacturer SRN: NO-MF-000051817
UDI-DI: 07090073130035
Basic UDI-DI: 709007313PRETECTTMJW
Reference: 400101
EMDN: W0104010204
EMDN description: SAMPLE TRANSPORT FOR NA TESTING
First on market country: Norway
Authorised representative: -
Last updated: 24.09.2026 14:46

Manufacturer products View details

PreTect X

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: PreTect AS
Manufacturer SRN: NO-MF-000051817
UDI-DI: 07090073130004
Basic UDI-DI: 709007313PRETECTX2T
Reference: 111001
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Norway
Authorised representative: -
Last updated: 24.09.2026 14:46

Manufacturer products View details

Folic Acid (FA) 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: 06942028501845
Basic UDI-DI: B-06942028501845
Reference: CJ0301
EMDN: W0102070103
EMDN description: FOLATE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 14:45

Manufacturer products Authorised representative products Authorised representative actors View details

Hemafix® Fixierlösung

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: BIOMED Labordiagnostik GmbH
Manufacturer SRN: DE-MF-000010310
UDI-DI: 04260481081929
Basic UDI-DI: 426048108STA00517F
Reference: 102302
EMDN: W01030705
EMDN description: FIXING REAGENTS (HISTOLOGY/CYTOLOGY)
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 14:45

Manufacturer products View details

IDK® Pankreatische Elastase ELISA

IDK® Pancreatic Elastase ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598008274
Basic UDI-DI: B-04050598008274
Reference: K 6915
EMDN: W0101060303
EMDN description: PANCREAS-ELASTASE
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 14:45

Manufacturer products View details

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010314
Basic UDI-DI: B-04050598010314
Reference: KSTDE001GP.02
EMDN: W0105060399
EMDN description: MYCOLOGY IMMUNOASSAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 14:45

Manufacturer products View details