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Last updated

01.08.2026 18:27

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Active filter:EMDN:W01050107

218 device results listed.

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GeneProof Mycobacterium tuberculosis PCR Kit

GeneProof Mycobacterium tuberculosis PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
GeneProof a.s.
Manufacturer SRN
CZ-MF-000002370
UDI-DI
08594161950097
Basic UDI-DI
B-08594161950097
Reference
MT/ISEX/025
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Czechia
Authorised representative
-
Last updated
08.07.2026 01:48
Manufacturer productsView details
GeneProof Mycobacterium tuberculosis PCR Kit

GeneProof Mycobacterium tuberculosis PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
GeneProof a.s.
Manufacturer SRN
CZ-MF-000002370
UDI-DI
08594161950110
Basic UDI-DI
B-08594161950110
Reference
MT/ISEX/100
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Czechia
Authorised representative
-
Last updated
08.07.2026 01:48
Manufacturer productsView details
06979502240006

"Mycobacterium Tuberculosis Specific Cell Mediated Immune Response Test Cassette (Rare earth nanorare earth nano fluorescence immunochromatography)"

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN
CN-MF-000012338
UDI-DI
06979502240006
Basic UDI-DI
B-06979502240006
Reference
IF031
EMDN
W0105010799
EMDN description
MYCOBACTERIA REAGENTS - OTHER
First on market country
Germany
Authorised representative
Luxus Lebenswelt GmbH
Last updated
07.07.2026 02:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Tuberculosis Rapid Test (Whole Blood/Serum/Plasma)

A480501T

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000037850
UDI-DI
06976753475843
Basic UDI-DI
B-06976753475843
Reference
A480501T
EMDN
W0105010799
EMDN description
MYCOBACTERIA REAGENTS - OTHER
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
07.07.2026 01:00
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
EUYI IP-10 Rapid Test for MTB

R48

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Shenzhen YOUYI Bioscience Ltd.
Manufacturer SRN
CN-MF-000034584
UDI-DI
06976457970040
Basic UDI-DI
B-06976457970040
Reference
100MTI-48
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Netherlands
Authorised representative
Umedwings Netherlands B.V.
Last updated
07.07.2026 00:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
EUYI MTB DNA Test

R48

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Shenzhen YOUYI Bioscience Ltd.
Manufacturer SRN
CN-MF-000034584
UDI-DI
06976457970026
Basic UDI-DI
B-06976457970026
Reference
100MTB-48
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Netherlands
Authorised representative
Umedwings Netherlands B.V.
Last updated
07.07.2026 00:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Tuberculosis IgG/IgM Rapid Test

GITBb

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000032462
UDI-DI
06976202762296
Basic UDI-DI
B-06976202762296
Reference
GITBb-402
EMDN
W0105010702
EMDN description
MYCOBACTERIAL ANTIBODY ASSAYS
First on market country
Italy
Authorised representative
Lotus NL B.V.
Last updated
07.07.2026 00:36
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06976055490155

4 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD
Manufacturer SRN
CN-MF-000033028
UDI-DI
06976055490155
Basic UDI-DI
B-06976055490155
Reference
NA
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Spain
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
07.07.2026 00:27
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06976055490148

8 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD
Manufacturer SRN
CN-MF-000033028
UDI-DI
06976055490148
Basic UDI-DI
B-06976055490148
Reference
NA
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Spain
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
07.07.2026 00:27
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Qpathnano Mycobacterium Typing and Drug Resistance Detection Kit

Qpathnano Mycobacterium Typing and Drug Resistance Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Qitan Taike Biotechnology Ltd., Chengdu
Manufacturer SRN
CN-MF-000040515
UDI-DI
06976019890137
Basic UDI-DI
B-06976019890137
Reference
OS005011
EMDN
W0105010799
EMDN description
MYCOBACTERIA REAGENTS - OTHER
First on market country
Greece
Authorised representative
MedPath GmbH
Last updated
07.07.2026 00:26
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Galaxy MTB/RIF Assay

12 reactions/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN
CN-MF-000001552
UDI-DI
06975447582119
Basic UDI-DI
B-06975447582119
Reference
106-0056-01
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Netherlands
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 22:50
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
VIUICK

Diagnostic Kit for Mycobacterium Tuberculosis DNA (Real-Time PCR Method)

IVD generalIVDDOn the marketKitReagentSingle use
Manufacturer
Guangzhou Viuick Biotechnology Co.,LTD.
Manufacturer SRN
CN-MF-000017369
UDI-DI
06975400320086
Basic UDI-DI
B-06975400320086
Reference
48 Tests/Kit
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Austria
Authorised representative
SUNGO Europe B.V.
Last updated
06.07.2026 22:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method)

Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hugomanu Beijing Co.,Ltd.
Manufacturer SRN
CN-MF-000023285
UDI-DI
06975384800055
Basic UDI-DI
B-06975384800055
Reference
YGZZ022-OS-D-000
EMDN
W0105010799
EMDN description
MYCOBACTERIA REAGENTS - OTHER
First on market country
Italy
Authorised representative
Abmed Medical Technology Limited
Last updated
06.07.2026 22:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MiniDock MTB Test

MTB Nucleic Acid Test Card

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN
CN-MF-000025784
UDI-DI
06975327120653
Basic UDI-DI
B-06975327120653
Reference
RM1012202-10
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
Medunion S.L.
Last updated
06.07.2026 22:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
POCBio Mycobacterium Tuberculosis (TB) Antibody Rapid Test

LATR02-C50

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Nexlab Co., Ltd.
Manufacturer SRN
CN-MF-000047094
UDI-DI
06974912094348
Basic UDI-DI
B-06974912094348
Reference
LATR02-C50
EMDN
W0105010702
EMDN description
MYCOBACTERIAL ANTIBODY ASSAYS
First on market country
France
Authorised representative
MedNet EC-REP GmbH
Last updated
06.07.2026 21:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06974858560228

Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000001080
UDI-DI
06974858560228
Basic UDI-DI
B-06974858560228
Reference
P121H
EMDN
W0105010703
EMDN description
MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country
Italy
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 20:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Tuberculosis Antibody Test Kit

Tuberculosis Antibody Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN
CN-MF-000035739
UDI-DI
06974854620650
Basic UDI-DI
B-06974854620650
Reference
P2201525
EMDN
W0105010702
EMDN description
MYCOBACTERIAL ANTIBODY ASSAYS
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 20:53
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details