- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- Manufacturer SRN
- CN-MF-000012807
- UDI-DI
- 06974849366365
- Basic UDI-DI
- B-06974849366365
- Reference
- HWTS-RT102A
- EMDN
- W0105010799
- EMDN description
- MYCOBACTERIA REAGENTS - OTHER
- First on market country
- Spain
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 06.07.2026 20:51
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
01.08.2026 18:27
Sync status
Successful
Device
2989865
Actor
47523
Certificate
3174
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
06974795550276
50 tests/kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- RocGene (Xuzhou) Technology Limited
- Manufacturer SRN
- CN-MF-000024511
- UDI-DI
- 06974795550276
- Basic UDI-DI
- B-06974795550276
- Reference
- 10210103B
- EMDN
- W0105010703
- EMDN description
- MYCOBACTERIAL DETECTION BY NA REAGENTS
- First on market country
- Italy
- Authorised representative
- Medunion S.L.
- Last updated
- 06.07.2026 20:43
06974795550269
10 tests/kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- RocGene (Xuzhou) Technology Limited
- Manufacturer SRN
- CN-MF-000024511
- UDI-DI
- 06974795550269
- Basic UDI-DI
- B-06974795550269
- Reference
- 10210103A
- EMDN
- W0105010703
- EMDN description
- MYCOBACTERIAL DETECTION BY NA REAGENTS
- First on market country
- Italy
- Authorised representative
- Medunion S.L.
- Last updated
- 06.07.2026 20:43
06974795550252
10 tests/kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- RocGene (Xuzhou) Technology Limited
- Manufacturer SRN
- CN-MF-000024511
- UDI-DI
- 06974795550252
- Basic UDI-DI
- B-06974795550252
- Reference
- 10210102A
- EMDN
- W0105010799
- EMDN description
- MYCOBACTERIA REAGENTS - OTHER
- First on market country
- Italy
- Authorised representative
- Medunion S.L.
- Last updated
- 06.07.2026 20:43
06974795550245
50 tests/kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- RocGene (Xuzhou) Technology Limited
- Manufacturer SRN
- CN-MF-000024511
- UDI-DI
- 06974795550245
- Basic UDI-DI
- B-06974795550245
- Reference
- 10210102B
- EMDN
- W0105010799
- EMDN description
- MYCOBACTERIA REAGENTS - OTHER
- First on market country
- Italy
- Authorised representative
- Medunion S.L.
- Last updated
- 06.07.2026 20:43
06974795550238
10 tests/kit
IVD generalIVDDOn the marketKitReagent
- Manufacturer
- RocGene (Xuzhou) Technology Limited
- Manufacturer SRN
- CN-MF-000024511
- UDI-DI
- 06974795550238
- Basic UDI-DI
- B-06974795550238
- Reference
- 10210001A
- EMDN
- W0105010703
- EMDN description
- MYCOBACTERIAL DETECTION BY NA REAGENTS
- First on market country
- Italy
- Authorised representative
- Medunion S.L.
- Last updated
- 06.07.2026 20:43
06974795550221
50 tests/kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- RocGene (Xuzhou) Technology Limited
- Manufacturer SRN
- CN-MF-000024511
- UDI-DI
- 06974795550221
- Basic UDI-DI
- B-06974795550221
- Reference
- 10210001B
- EMDN
- W0105010703
- EMDN description
- MYCOBACTERIAL DETECTION BY NA REAGENTS
- First on market country
- Italy
- Authorised representative
- Medunion S.L.
- Last updated
- 06.07.2026 20:43
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
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
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
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
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
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
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
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
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
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
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
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
(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