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06941967238546

CR-I

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967238546
Basic UDI-DI: 69732628600062ZU
Reference: 0400508
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 13:51

Manufacturer products Authorised representative products Authorised representative actors View details

06941967236856

H58 DR

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967236856
Basic UDI-DI: 69732628600125ZT
Reference: 0400930
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.09.2026 13:51

Manufacturer products Authorised representative products Authorised representative actors View details

06941967235927

Cell-free DNA Extraction Kit (Magnetic Bead Method)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967235927
Basic UDI-DI: 69732628600111ZG
Reference: 0301807
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.09.2026 13:50

Manufacturer products Authorised representative products Authorised representative actors View details

EntericBio® Viral Panel 2

IVD generalNot specifiedOn the market

Manufacturer: Serosep Limited
Manufacturer SRN: IE-MF-000020322
UDI-DI: 05391513879258
Basic UDI-DI: B-05391513879258
Reference: EBVP2
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Ireland
Authorised representative: -
Last updated: 24.09.2026 13:50

Manufacturer products View details

06941967234012

TH-PDesorb

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967234012
Basic UDI-DI: 69732628600104ZK
Reference: 1301114
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 13:50

Manufacturer products Authorised representative products Authorised representative actors View details

06941967225799

CAL

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

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967225799
Basic UDI-DI: 697326286000872F
Reference: 0402801
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 13:50

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224365

Z5 LB

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224365
Basic UDI-DI: 69732628600012ZD
Reference: 01.09.31.05.Z5.36
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 24.09.2026 13:50

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: 06921963723000
Basic UDI-DI: 692196371531J2
Reference: 1N40C5-9
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Croatia
Safety summary (SSCP/SSP): RR1N40040-R · Rev. A05
Authorised representative: Lotus NL B.V.
Last updated: 24.09.2026 13:50

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

Anti-beta 2 Glycoprotein 1 Antibody IgA/G/M (β2-GP1-IgA/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: 06942028502200
Basic UDI-DI: B-06942028502200
Reference: DB2001
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 13:45

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Human Chorionic Gonadotropin antibody (HCG-Ab) 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: 06942028501968
Basic UDI-DI: B-06942028501968
Reference: DB1401
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 13:45

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Antigen Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622072
Basic UDI-DI: B-06938384622072
Reference: LQ-000401
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 13:45

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-zona pellucida antibody IgG(ZP-IgG) 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: 06942028501883
Basic UDI-DI: B-06942028501883
Reference: DB1201
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 13:45

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384622089
Basic UDI-DI: B-06938384622089
Reference: LX-401301
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - 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 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