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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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SARS-CoV-2 Test Kit

SARS-CoV-2 Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703259
Basic UDI-DI: B-06956299703259
Reference: 801304
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

MTB Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702979
Basic UDI-DI: B-06956299702979
Reference: 801219
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

MTB/PZA Test Kit

MTB/PZA Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702962
Basic UDI-DI: B-06956299702962
Reference: 801218
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

MTB/STR Test Kit (MMCA)

MTB/STR Test Kit (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702955
Basic UDI-DI: B-06956299702955
Reference: 801217
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

MTB/EMB Test Kit (MMCA)

MTB/EMB Test Kit (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702948
Basic UDI-DI: B-06956299702948
Reference: 801216
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

MDR-TB Test Kit (MMCA)

MDR-TB Test Kit (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702917
Basic UDI-DI: B-06956299702917
Reference: 801213
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacteria Identification Kit (MMCA)

Mycobacteria Identification Kit (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702900
Basic UDI-DI: B-06956299702900
Reference: 801210
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

MTB/SL Test Kit (MMCA)

MTB/SL Test Kit (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702894
Basic UDI-DI: B-06956299702894
Reference: 801206
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

MTB/FQ Test Kit (MMCA)

MTB/FQ Test Kit (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702887
Basic UDI-DI: B-06956299702887
Reference: 801205
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

MTB/MDR Test Kit (Sanity 2.0)

MTB/MDR Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702870
Basic UDI-DI: B-06956299702870
Reference: 801181
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacteria Identification Kit (Sanity 2.0)

Mycobacteria Identification Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702863
Basic UDI-DI: B-06956299702863
Reference: 801180
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

MDR-TB Test Kit (Sanity 2.0)

MDR-TB Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702856
Basic UDI-DI: B-06956299702856
Reference: 801177
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

MTB Test Kit (Sanity 2.0)

MTB Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702849
Basic UDI-DI: B-06956299702849
Reference: 801176
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test Kit (Sanity 2.0)

SARS-CoV-2 Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702832
Basic UDI-DI: B-06956299702832
Reference: 801307
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Pathogen Panel (RPP4D)

Respiratory Pathogen Panel (RPP4D)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702788
Basic UDI-DI: B-06956299702788
Reference: 801113
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity-2 Respiratory Pathogen Panel (RPP4)

Sanity-2 Respiratory Pathogen Panel (RPP4)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702771
Basic UDI-DI: B-06956299702771
Reference: 801112
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

Low Risk HPV Genotyping Assay

Low Risk HPV Genotyping Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702740
Basic UDI-DI: B-06956299702740
Reference: 801013
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

High Risk HPV Genotyping Assay (MMCA)

High Risk HPV Cenotyping Assay (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702733
Basic UDI-DI: B-06956299702733
Reference: 801011
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

High Risk HPV Genotyping Kit (Sanity 2.0)

High Risk HPV Genotyping Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702726
Basic UDI-DI: B-06956299702726
Reference: 801170
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214524393
Basic UDI-DI: 868521452PCR158GK
Reference: LYO158WS48
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:58

Manufacturer products View details