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70 device results listed.

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Genedrive® System

IVD Class ANot specifiedOn the market

Manufacturer: Genedrive Diagnostics Ltd.
Manufacturer SRN: GB-MF-000012810
UDI-DI: 05060654860677
Basic UDI-DI: 506065486GS-00X2F
Reference: GS-003 V4.0
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 20.06.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Genedrive® System

IVD Class ANot specifiedOn the market

Manufacturer: Genedrive Diagnostics Ltd.
Manufacturer SRN: GB-MF-000012810
UDI-DI: 05060654860417
Basic UDI-DI: 506065486GS-00X2F
Reference: GS-002 V6.0
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Greece
Authorised representative: Advena Limited
Last updated: 20.06.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

06973316740288

IVD Class AIVDR 2017/746Not intended for EU marketCompanion diagnosticsInstrumentNear-patient testingProfessional testing

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740288
Basic UDI-DI: 697331674PCR01KE
Reference: A211012
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

06973316740295

IVD Class AIVDR 2017/746Not intended for EU marketCompanion diagnosticsInstrumentNear-patient testingProfessional testing

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740295
Basic UDI-DI: 697331674PCR01KE
Reference: A211013
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

06973316740301

IVD Class AIVDR 2017/746Not intended for EU marketCompanion diagnosticsInstrumentNear-patient testingProfessional testing

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740301
Basic UDI-DI: 697331674PCR01KE
Reference: A211014
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

MultNAT Molecular Diagnostic Testing System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240626
Basic UDI-DI: 697349224U3000027A000ET
Reference: U300002-4
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565219

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565219
Basic UDI-DI: 697454156006L5
Reference: BTK-1
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

06974795551990

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795551990
Basic UDI-DI: 697479555iFIND6K
Reference: iFIND S4
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974795552003

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795552003
Basic UDI-DI: 697479555iFIND6K
Reference: iFIND S8
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Rapi Q HT - Micro RT PCR System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200704
Basic UDI-DI: 890617820IG2M5001KQ
Reference: -
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 27.05.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details