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

TREN

Last updated

23.09.2026 08:13

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Device

3540991

Actor

47794

Certificate

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Active filter:EMDN:W01050107

277 device results listed.

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FlashDetect

FlashDetect™ LyocartE MTB Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Coyote Bioscience Co., Ltd.
Manufacturer SRN
CN-MF-000024155
UDI-DI
06974767393061
Basic UDI-DI
B-06974767393061
Reference
6018013905-CE
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Sweden
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 20:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
FlashDetect

FlashDetect™ LyocartE MTB Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Coyote Bioscience Co., Ltd.
Manufacturer SRN
CN-MF-000024155
UDI-DI
06974767393054
Basic UDI-DI
B-06974767393054
Reference
6018013902-CE
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Sweden
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 20:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN
CN-MF-000022829
UDI-DI
06974674892503
Basic UDI-DI
B-06974674892503
Reference
18-01-0010
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 20:16
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
NTM Drugs Susceptibility Test Kit

10Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000019361
UDI-DI
06974566304091
Basic UDI-DI
B-06974566304091
Reference
PNTM010
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Denmark
Authorised representative
Medunion S.L.
Last updated
06.07.2026 19:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
NTM Drug Resistance Gene Mutation Detection Kit(Fluorescence PCR Melting Curve Analysis)

24Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000019361
UDI-DI
06974566304084
Basic UDI-DI
B-06974566304084
Reference
PNTM0424
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Denmark
Authorised representative
Medunion S.L.
Last updated
06.07.2026 19:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
NTM Drug Resistance Gene Mutation Detection Kit(Fluorescence PCR Melting Curve Analysis)

48Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000019361
UDI-DI
06974566304077
Basic UDI-DI
B-06974566304077
Reference
PNTM0448
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Finland
Authorised representative
Medunion S.L.
Last updated
06.07.2026 19:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis)

48Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000019361
UDI-DI
06974566304060
Basic UDI-DI
B-06974566304060
Reference
PNTM048
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Denmark
Authorised representative
Medunion S.L.
Last updated
06.07.2026 19:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis)

24Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000019361
UDI-DI
06974566304053
Basic UDI-DI
B-06974566304053
Reference
PNTM024
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Greece
Authorised representative
Medunion S.L.
Last updated
06.07.2026 19:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)

MTB and Drug Resistance Gene Mutation Detection Kit 48tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000019361
UDI-DI
06974566304046
Basic UDI-DI
B-06974566304046
Reference
PMTB0548
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Bulgaria
Authorised representative
Medunion S.L.
Last updated
06.07.2026 19:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)

MTB and RFP/INH Drug Resistance Gene Mutation Detection Kit 24tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000019361
UDI-DI
06974566304022
Basic UDI-DI
B-06974566304022
Reference
PMTB0524
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
Medunion S.L.
Last updated
06.07.2026 19:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)

MTB and RFP/INH Drug Resistance Gene Mutation Detection Kit 48tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000019361
UDI-DI
06974566304015
Basic UDI-DI
B-06974566304015
Reference
PMTB0348
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
Medunion S.L.
Last updated
06.07.2026 19:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)

MTB and RFP Drug Resistance Gene Mutation Detection Kit 48tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000019361
UDI-DI
06974566304008
Basic UDI-DI
B-06974566304008
Reference
PMTB0248
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Austria
Authorised representative
Medunion S.L.
Last updated
06.07.2026 19:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
(Fluorescence PCR Melting Curve Analysis)

MTB and RFP Drug Resistance Gene Mutation Detection Kit 24 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000019361
UDI-DI
06974566303995
Basic UDI-DI
B-06974566303995
Reference
PMTB0224
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Bulgaria
Authorised representative
Medunion S.L.
Last updated
06.07.2026 19:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Tuberculosis Antibody Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000019361
UDI-DI
06974566302820
Basic UDI-DI
B-06974566302820
Reference
ITA-812
EMDN
W0105010702
EMDN description
MYCOBACTERIAL ANTIBODY ASSAYS
First on market country
Denmark
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 19:53
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details