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Sample Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: HILEAP Medtech (Nantong) Corp.
Manufacturer SRN: CN-MF-000037836
UDI-DI: 06975403050010
Basic UDI-DI: 697540305YX3E
Reference: 0.5mL
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

06975200381140

Sample Dilution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Xilaiheng Medical Electronics Co.,Ltd.
Manufacturer SRN: CN-MF-000047090
UDI-DI: 06975200381140
Basic UDI-DI: 697520038114GE
Reference: D103
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Spain
Authorised representative: HUMISS TRADING S. L.
Last updated: 02.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

06975200381133

Cleaning Solution

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Shenzhen Xilaiheng Medical Electronics Co.,Ltd.
Manufacturer SRN: CN-MF-000047090
UDI-DI: 06975200381133
Basic UDI-DI: 697520038113GC
Reference: D104
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 02.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

06974898111732

Reagent for removal of DNA contaminations

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

Manufacturer: GENFINE BIOTECH(CHANGZHOU) CO.,LTD
Manufacturer SRN: CN-MF-000003399
UDI-DI: 06974898111732
Basic UDI-DI: 697489811000009ZL
Reference: 250mL/bottle
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

06974776970017

96tests/kit, 120tests/kit, 144tests/kit, 160tests/kit, 480tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: CapitalBio Genomics Co.,Ltd.
Manufacturer SRN: CN-MF-000027716
UDI-DI: 06974776970017
Basic UDI-DI: 697477697NAEPK019V
Reference: 96tests/kit
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:27

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Cleaning Solution (FI)

Cleaning Solution (FI)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361511
Basic UDI-DI: 697473536KUC14PP
Reference: KU-FW01
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Iodine Solution

KU-FI01

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361474
Basic UDI-DI: 697473536KUC13PM
Reference: KU-FI01
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

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

16974573530114

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

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

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

06974541565066

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