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IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546065
Basic UDI-DI: 697015090000319HL
Reference: CMQ2703
EMDN: W0102060199
EMDN description: DIABETES ASSAYS - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automated HbA1c Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384641509
Basic UDI-DI: 69383846TY003XS
Reference: L-800101
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:40

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Dengue IgM/IgG Rapid test (Colloidal Gold)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700408850
Basic UDI-DI: 697029753448M2
Reference: HGCG13
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:40

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One Step Syphilis Anti-TP Test (Colloidal Gold)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700408812
Basic UDI-DI: 697029753446LW
Reference: HGCG06
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:40

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Diluents for Hematology Analyzers Use

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611014
Basic UDI-DI: 69383846XQ063XY
Reference: L-03H79-01
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:39

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Diluents for Hematology Analyzers Use

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611021
Basic UDI-DI: 69383846XQ063XY
Reference: L-99231-01
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:39

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Diluents for Hematology Analyzers Use

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611038
Basic UDI-DI: 69383846XQ063XY
Reference: 33-10-020
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

Preventis SmarTest Pro® Vitamin D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598008632
Basic UDI-DI: B-04050598008632
Reference: PST80100G5
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 13:39

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Diluents for Hematology Analyzers Use

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611045
Basic UDI-DI: 69383846XQ063XY
Reference: 20-10-020-W
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:39

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Diluents for Hematology Analyzers Use

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611052
Basic UDI-DI: 69383846XQ063XY
Reference: L-8546733
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:39

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Diluents for Hematology Analyzers Use

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611069
Basic UDI-DI: 69383846XQ063XY
Reference: 77-10-015
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

Diluents for Hematology Analyzers Use

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611076
Basic UDI-DI: 69383846XQ063XY
Reference: L-8547169
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

Diluents for Hematology Analyzers Use

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611083
Basic UDI-DI: 69383846XQ063XY
Reference: L-58D
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

Diluents for Hematology Analyzers Use

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611090
Basic UDI-DI: 69383846XQ063XY
Reference: L-50D
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

Diluents for Hematology Analyzers Use

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611106
Basic UDI-DI: 69383846XQ063XY
Reference: L-53D
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

Diluents for Hematology Analyzers Use

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611113
Basic UDI-DI: 69383846XQ063XY
Reference: L-3020
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

ID-Vit® Vitamin B2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598001244
Basic UDI-DI: B-04050598001244
Reference: KIF002S
EMDN: W0102070202
EMDN description: VITAMIN B2
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 13:39

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Diluents for Hematology Analyzers Use

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611120
Basic UDI-DI: 69383846XQ063XY
Reference: L-3010
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

Preventis SmarTest Pro® Vitamin D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598008649
Basic UDI-DI: B-04050598008649
Reference: PST80100GP
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 13:38

Manufacturer products View details

Diluents for Hematology Analyzers Use

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611144
Basic UDI-DI: 69383846XQ063XY
Reference: R-1710
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details