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585 device results listed.

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Nucleic acid extraction reagent

Pathogens TNA-B1、Pathogens TNA-P1、Pathogens TNA-P2

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689624144
Basic UDI-DI: 697468962507SE
Reference: 11020
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid release reagent

easyTNA -B1、easyTNA -T1

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689624120
Basic UDI-DI: 697468962505SA
Reference: 11118
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction reagent (cell DNA)

CELL DNA-B1、CELL DNA-P1

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689624106
Basic UDI-DI: 697468962504S8
Reference: N/A
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction reagent

B1、P1、P2、P3

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689624090
Basic UDI-DI: 697468962520S6
Reference: 11123
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid release agent (DNA )

easyDNA -B1、easyDNA -T1

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689624083
Basic UDI-DI: 697468962511S5
Reference: 11128
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction reagent (FFPE DNA)

FFPE DNA-B1、FFPE DNA-P1

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689624076
Basic UDI-DI: 697468962503S6
Reference: 11111
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction reagent (FFPE TNA)

FFPE TNA-B1、FFPE TNA-B2、FFPE TNA-P1、FFPE TNA-P2

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689624045
Basic UDI-DI: 697468962502S4
Reference: 11107
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction Reagent

B1、P1

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689624038
Basic UDI-DI: 697468962512S7
Reference: 11105
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction reagent (cfDNA)

Model: cfDNA-B1 Specification: 1 ml×64 tests, 2 ml×64 tests, 4 ml×64 tests

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689624014
Basic UDI-DI: 697468962501S2
Reference: 11115
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

06

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingReagent

Manufacturer: Suzhou CellPro Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000008875
UDI-DI: 16974573530114
Basic UDI-DI: 6974573530000016Q7
Reference: N/A
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:42

Manufacturer products Authorised representative products Authorised representative actors View details

Aucheer iMAGIN Wash Buffer

Aucheer iMAGIN Wash Buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038081
UDI-DI: 06974546541270
Basic UDI-DI: 697454654QX67
Reference: 1000ml/bottle
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

Aucheer iMAGIN Trigger Solution

Aucheer iMAGIN Trigger Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038081
UDI-DI: 06974546541294
Basic UDI-DI: 697454654JF4E
Reference: for iMAGIN 1800
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

ZK1000,ZK1500

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565066
Basic UDI-DI: 697454156007L7
Reference: ZK1000
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

DP4611,DP4612,DP4613,AU17011,AU17012,AU18012,AU18012-96,AU1811,AU1812,AU52111

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564939
Basic UDI-DI: 697454156002KV
Reference: DP4611
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

32T/Kit,64T/Kit.

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: MABSKY BIO-TECH CO., LTD.
Manufacturer SRN: CN-MF-000038680
UDI-DI: 06974195301621
Basic UDI-DI: 6974195307321052SKY012877
Reference: SKYE203-8
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction Reagent

DRNAB

IVD Class AIVDR 2017/746No longer on the marketKitProfessional testingReagent

Manufacturer: Shenzhen Dakewe Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000002174
UDI-DI: 06973471967322
Basic UDI-DI: 697347196893NAEAX
Reference: 8934011
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details

Cell Preservation Solution

-

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: 06973342003890
Basic UDI-DI: 697334200SR10110B4
Reference: SR10110
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

VAMNE MaqUltra Circulating Cell-free DNA lsolation Mini Kit (Prepackaged)VAMNE MagUltra Circulating Cell-free DNA Isolation Mini Kit (Prepackaged)

N904-C1ME

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736367
Basic UDI-DI: 6973315736367AR
Reference: N904-C1ME
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Red Cell Preservative Fluid

Red Cell Preservative Fluid

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsHuman tissuesProfessional testingReagentSingle use

Manufacturer: Junocare Medical Devices Ltd
Manufacturer SRN: CN-MF-000030653
UDI-DI: 06973094411127
Basic UDI-DI: 697309441RedFluiUC
Reference: CVG1RCPF3600
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 13:37

Manufacturer products Authorised representative products Authorised representative actors View details

Density Reagent

Density Reagent

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsHuman tissuesProfessional testingReagentSingle use

Manufacturer: Junocare Medical Devices Ltd
Manufacturer SRN: CN-MF-000030653
UDI-DI: 06973094411103
Basic UDI-DI: 697309441DensityZJ
Reference: CVG1DR480
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 13:37

Manufacturer products Authorised representative products Authorised representative actors View details