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EUDAMED Device Search

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

TREN

Last updated

23.09.2026 00:13

Sync status

Successful

Device

3539602

Actor

47778

Certificate

3398

Active filter:Manufacturer SRN:CN-MF-000047336

365 device results listed.

Page 3 / 19

CSVXML
Thyroglobulin Assay kit(Chemiluminescence Immunoassay Method）

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

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465230956
Basic UDI-DI
697846523HormoneB06HZ
Reference
2×100 test
EMDN
W01020408
EMDN description
THYROGLOBULIN
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
02.07.2026 23:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Free Thyroxine Assay kit(Chemiluminescence Immunoassay Method）

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

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465230857
Basic UDI-DI
697846523HormoneB04HV
Reference
2×100 test
EMDN
W01020402
EMDN description
FREE THYROXINE
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
02.07.2026 23:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Free Triiodothyronine Assay kit(Chemiluminescence Immunoassay Method）

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

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465230659
Basic UDI-DI
697846523HormoneB02HR
Reference
2×100 test
EMDN
W01020401
EMDN description
FREE TRIIODOTHYRONINE
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
02.07.2026 23:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Total Triiodothyronine Assay kit(Chemiluminescence Immunoassay Method）

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

IVD Class BIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465230550
Basic UDI-DI
697846523HormoneB01HP
Reference
2×100- est
EMDN
W01020405
EMDN description
TRIIODOTHYRONINE
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
02.07.2026 23:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Total Thyroxine Assay kit(Chemiluminescence Immunoassay Method）

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

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465230758
Basic UDI-DI
697846523HormoneB03HT
Reference
2×100 test
EMDN
W01020407
EMDN description
THYROXINE
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
02.07.2026 23:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Thyroid Stimulating Hormone Assay kit(Chemiluminescence Immunoassay Method）

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

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465230451
Basic UDI-DI
697846523HormoneB05HX
Reference
2×100 test
EMDN
W01020410
EMDN description
THYROID STIMULATING HORMONE
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
02.07.2026 23:33
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06978465230192

Bright i60 Series (including Bright i30, Bright i36, Bright i38, Bright i39,Bright i60, Bright i66, Bright i68, Bright i69 models); Bright i100 Series (includingBright i100, Bright i160, Bright i180, Bright i190 models); etc

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465230192
Basic UDI-DI
697846523FACIAN3
Reference
Bright i60 Series Bright i30
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
Austria
Authorised representative
SUNGO Europe B.V.
Last updated
02.07.2026 23:33
Manufacturer productsAuthorised representative productsAuthorised representative actorsView 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
06978465238136
Basic UDI-DI
697846523TumorC019V
Reference
100 tests
EMDN
W0102039001
EMDN description
ALPHAFETOPROTEIN
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView 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
06978465238129
Basic UDI-DI
697846523TumorC019V
Reference
50 tests
EMDN
W0102039001
EMDN description
ALPHAFETOPROTEIN
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView 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
06978465238112
Basic UDI-DI
697846523TumorC019V
Reference
25 tests
EMDN
W0102039001
EMDN description
ALPHAFETOPROTEIN
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-Dimer Assay kit 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
06978465238044
Basic UDI-DI
697846523OtherC01YT
Reference
100 tests
EMDN
W0103020503
EMDN description
D-DIMER
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-Dimer Assay kit 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
06978465238037
Basic UDI-DI
697846523OtherC01YT
Reference
50 tests
EMDN
W0103020503
EMDN description
D-DIMER
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-Dimer Assay kit 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
06978465238020
Basic UDI-DI
697846523OtherC01YT
Reference
25 tests
EMDN
W0103020503
EMDN description
D-DIMER
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Lipoprotein-associated Phospholipase A2 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
06978465237986
Basic UDI-DI
697846523enzymeC03U8
Reference
100 tests
EMDN
W01021312
EMDN description
LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Lipoprotein-associated Phospholipase A2 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
06978465237979
Basic UDI-DI
697846523enzymeC03U8
Reference
50 tests
EMDN
W01021312
EMDN description
LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Lipoprotein-associated Phospholipase A2 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
06978465237962
Basic UDI-DI
697846523enzymeC03U8
Reference
25 tests
EMDN
W01021312
EMDN description
LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Creatine Kinase MB 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
06978465237955
Basic UDI-DI
697846523enzymeC02U6
Reference
100 tests
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Creatine Kinase MB 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
06978465237948
Basic UDI-DI
697846523enzymeC02U6
Reference
50 tests
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Creatine Kinase MB 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
06978465237931
Basic UDI-DI
697846523enzymeC02U6
Reference
25 tests
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Pro-gastrin-releasing peptide 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
06978465237412
Basic UDI-DI
697846523ProteinC09RV
Reference
100 tests
EMDN
W0102030121
EMDN description
PRO-GASTRIN-RELEASING PEPTIDE
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details