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SARS-CoV-2 Antigen and Influenza A/B Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622096
Basic UDI-DI: B-06938384622096
Reference: LX-401401
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Flu A/Flu B/RSV/ADV/MP Antigen Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622102
Basic UDI-DI: B-06938384622102
Reference: LX-403101
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Flu A/Flu B/RSV/ADV Antigen Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622119
Basic UDI-DI: B-06938384622119
Reference: LX-403201
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-zona pellucida antibody IgM(ZP-IgM) Detection 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: 06942028501920
Basic UDI-DI: B-06942028501920
Reference: DB1301
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Antigen Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622218
Basic UDI-DI: B-06938384622218
Reference: LX-401501
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Antibody Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622225
Basic UDI-DI: B-06938384622225
Reference: LX-403401
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

H. Pylori Antigen Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622232
Basic UDI-DI: B-06938384622232
Reference: LX-403901
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

H. Pylori Antibody Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622249
Basic UDI-DI: B-06938384622249
Reference: LX-404001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-cardiolipin antibody IgA/G/M (aCL-A/G/M) 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: 06942028502040
Basic UDI-DI: B-06942028502040
Reference: DB1601
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 13:44

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: 06938384641110
Basic UDI-DI: 69383846TY001XN
Reference: L-800601
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 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automated HbA1c Analyzer

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384641127
Basic UDI-DI: 69383846TY001XN
Reference: L-800602
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 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automated HbA1c Analyzer

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384641134
Basic UDI-DI: 69383846TY001XN
Reference: L-800603
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 13:42

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: 06938384641219
Basic UDI-DI: 69383846TY002XQ
Reference: L-800401
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 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2 Antigen Test Card

IVD Class CIVDR 2017/746On the marketDirect markingKitReagentSelf testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963723024
Basic UDI-DI: 692196371531J2
Reference: 1N40C5-8
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: -
Safety summary (SSCP/SSP): RR1N40040-R · Rev. A05
Authorised representative: Lotus NL B.V.
Last updated: 24.09.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Fully Automated HbA1c Analyzer

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384641226
Basic UDI-DI: 69383846TY002XQ
Reference: L-800402
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 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

POCT HbA1c Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384641448
Basic UDI-DI: 69383846TY004XU
Reference: L-800501
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

POCT HbA1c Analyzer

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384641455
Basic UDI-DI: 69383846TY004XU
Reference: L-800502
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

POCT HbA1c Analyzer

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384641462
Basic UDI-DI: 69383846TY004XU
Reference: L-800503
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

CITOSWAB

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: CITOTEST LABWARE MANUFACTURING CO.,LTD
Manufacturer SRN: CN-MF-000017214
UDI-DI: 06942826221914
Basic UDI-DI: 697079159SAKA000A00NG9
Reference: 2118-1761
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 24.09.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details

Automated HbA1c Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384641479
Basic UDI-DI: 69383846TY006XY
Reference: L-800504
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details