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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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08.10.2026 13:27

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Diagnostic Kit for Antigen to Rotavirus/Adenoviruses (Latex)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-533310NY
Basic UDI-DI: B-533310NY
Reference: 53331001,53331005,53331020,53331025
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Antigen to Rotavirus (Latex)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-5333081XY
Basic UDI-DI: B-5333081XY
Reference: 53330801, 53330805, 53330820, 53330825
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Antibody Subtype to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-533306P9
Basic UDI-DI: B-533306P9
Reference: 51333901,51333905,51333920,51333925
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Ferritin (fluorescence immunochromatographic assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-533221018J
Basic UDI-DI: B-533221018J
Reference: 53322101,53322105,53322120,53322125
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Glycosylated Hemoglobin A1c (fluorescence immunochromatographic assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-533215P5
Basic UDI-DI: B-533215P5
Reference: 53321501,53321505,53321520,53321525
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Pepsinogen I /Pepsinogen Ⅱ (fluorescence immunochromatographic assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-533212NX
Basic UDI-DI: B-533212NX
Reference: 53321201,53321205,53321220,53321225
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Gastrin-17 (fluorescence immunochromatographic assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-533211NV
Basic UDI-DI: B-533211NV
Reference: 53321101,53321105,53321120,53321125
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for 25-hydroxy Vitamin D (fluorescence immunochromatographic assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-533210NT
Basic UDI-DI: B-533210NT
Reference: 53321001,53321005,53321020,53321025
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Total Thyroxine (fluorescence immunochromatographic assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-53311GE
Basic UDI-DI: B-53311GE
Reference: 53311501,53311505,53311520,53311525
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Total Triiodothyronine (fluorescence immunochromatographic assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-533114NW
Basic UDI-DI: B-533114NW
Reference: 53311401,53311405,53311420,53311425
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Prolactin (fluorescence immunochromatographic assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-533113NU
Basic UDI-DI: B-533113NU
Reference: 53311301,53311305,53311320,53311325
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Testosterone (fluorescence immunochromatographic assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-533112NS
Basic UDI-DI: B-533112NS
Reference: 53311201,53311205,53311220,53311225
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Anti-mullerian hormone (fluorescence immunochromatographic assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-533107NZ
Basic UDI-DI: B-533107NZ
Reference: 53310701,53310705,53310720,53310725
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibodies Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-532321NW
Basic UDI-DI: B-532321NW
Reference: 53232101,53232102,53232103,53232104
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Serum Amyloid A (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-532227P5
Basic UDI-DI: B-532227P5
Reference: 53222711,53222715,53222720,53222725
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Cardiac Troponin I/Isoenzyme MB of Creatine Kinase/Myoglobin(Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-523509PE
Basic UDI-DI: B-523509PE
Reference: 52350901,52350905,52350920,52350925
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Portugal
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Pro-brain natriuretic peptide to amino-terminal (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-523507PA
Basic UDI-DI: B-523507PA
Reference: 52350701,52350705,52350720,52350725
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Antigen to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-523307NY
Basic UDI-DI: B-523307NY
Reference: 52330701,52330705,52330720,52330725
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Interleukin-6 (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-523235NY
Basic UDI-DI: B-523235NY
Reference: 52323501,52323505,52323520,52323525
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Procalcitonin/Interleukin- 6 (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: D-523230NN
Basic UDI-DI: B-523230NN
Reference: 52323001,52323005,52323020,52323025
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 06.10.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details