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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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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

Violeta Cristal (6x250 mL)

-

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155005466
Basic UDI-DI: 8430155GRAMPVPWF
Reference: 999913
EMDN: W0104010804
EMDN description: STAINS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:58

Manufacturer products View details

COC Rapid Test Cassette

COC Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277510578
Basic UDI-DI: B-06970277510578
Reference: DCO-102
EMDN: W0102160506
EMDN description: COCAINE + COCAINE METABOLITES - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE Salmonella, Campylobacter & Y. enterocolitica Real Time PCR Detection Kit

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440227670
Basic UDI-DI: 84354402_MDXGASTROB_SCYT3
Reference: VS-SCY101L
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:55

Manufacturer products View details

VIASURE Salmonella, Campylobacter & Y. enterocolitica Real Time PCR Detection Kit

VIASURE Salmonella, Campylobacter & Y. enterocolitica Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440202356
Basic UDI-DI: 84354402_MDXGASTROB_SCYT3
Reference: VS-SCY112L
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 03.08.2026 22:55

Manufacturer products View details

PRL30 PIPERACILLIN

-

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384084654
Basic UDI-DI: 5032384PiperacillinQD
Reference: CT1619B
EMDN: W0104080502
EMDN description: IMPREGNATED DISKS, MULTI-DISKS & TABLETS
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

PRL100 PIPERACILLIN

PIPERACILLIN

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384006502
Basic UDI-DI: 5032384PiperacillinQD
Reference: CT0199B
EMDN: W0104080502
EMDN description: IMPREGNATED DISKS, MULTI-DISKS & TABLETS
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

RIFAMPICIN

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384006526
Basic UDI-DI: 5032384RifampicinHU
Reference: CT0207B
EMDN: W0104080502
EMDN description: IMPREGNATED DISKS, MULTI-DISKS & TABLETS
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details