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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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24.09.2026 17:24

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Active filter:Manufacturer SRN:CN-MF-000047336

365 device results listed.

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High Sensitive Cardiac Troponin I Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465232158
Basic UDI-DI: 697846523ProteinC10RE
Reference: 2×100 test
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:20

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230154
Basic UDI-DI: 697846523TumorC019V
Reference: 2×100 test
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:20

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230208
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230215
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230222
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230239
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230246
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230253
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230260
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230277
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230284
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230291
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230307
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230314
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230321
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230338
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230345
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230352
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230369
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230376
Basic UDI-DI: 697846523FACIAN3
Reference: N/A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details