UTSBridge

Public EUDAMED Search

EUDAMED Device Search

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

TREN

Last updated

23.09.2026 08:13

Sync status

Successful

Device

3541299

Actor

47800

Certificate

3399

Active filter:Manufacturer SRN:CN-MF-000047336

365 device results listed.

Page 5 / 19

CSVXML
Carcinoembryonic Antigen 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
06978465237207
Basic UDI-DI
697846523ProteinC02RF
Reference
100 tests
EMDN
W0102030112
EMDN description
CARCINOEMBRYONIC ANTIGEN
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:25
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Carcinoembryonic Antigen 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
06978465237191
Basic UDI-DI
697846523ProteinC02RF
Reference
50 tests
EMDN
W0102030112
EMDN description
CARCINOEMBRYONIC ANTIGEN
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Carcinoembryonic Antigen 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
06978465237184
Basic UDI-DI
697846523ProteinC02RF
Reference
25 tests
EMDN
W0102030112
EMDN description
CARCINOEMBRYONIC ANTIGEN
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Heart-type Fatty Acid-Binding Protein 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
06978465237177
Basic UDI-DI
697846523ProteinC15RQ
Reference
100 tests
EMDN
W0102160705
EMDN description
HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Heart-type Fatty Acid-Binding Protein 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
06978465237160
Basic UDI-DI
697846523ProteinC15RQ
Reference
50 tests
EMDN
W0102160705
EMDN description
HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Heart-type Fatty Acid-Binding Protein 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
06978465237153
Basic UDI-DI
697846523ProteinC15RQ
Reference
25 tests
EMDN
W0102160705
EMDN description
HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
B-type natriuretic 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
06978465237146
Basic UDI-DI
697846523ProteinC13RL
Reference
100 tests
EMDN
W01021301
EMDN description
BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
B-type natriuretic 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
06978465237139
Basic UDI-DI
697846523ProteinC13RL
Reference
50 tests
EMDN
W01021301
EMDN description
BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
B-type natriuretic 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
06978465237122
Basic UDI-DI
697846523ProteinC13RL
Reference
25 tests
EMDN
W01021301
EMDN description
BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
N-terminal pro B-type natriuretic 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
06978465237115
Basic UDI-DI
697846523ProteinC11RG
Reference
100 tests
EMDN
W01021301
EMDN description
BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
N-terminal pro B-type natriuretic 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
06978465237108
Basic UDI-DI
697846523ProteinC11RG
Reference
50 tests
EMDN
W01021301
EMDN description
BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
N-terminal pro B-type natriuretic 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
06978465237092
Basic UDI-DI
697846523ProteinC11RG
Reference
25 tests
EMDN
W01021301
EMDN description
BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Myoglobin 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
06978465237085
Basic UDI-DI
697846523ProteinC14RN
Reference
100 tests
EMDN
W01021304
EMDN description
MYOGLOBIN
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Myoglobin 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
06978465237078
Basic UDI-DI
697846523ProteinC14RN
Reference
50 tests
EMDN
W01021304
EMDN description
MYOGLOBIN
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Myoglobin 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
06978465237061
Basic UDI-DI
697846523ProteinC14RN
Reference
25 tests
EMDN
W01021304
EMDN description
MYOGLOBIN
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
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
06978465237054
Basic UDI-DI
697846523ProteinC10RE
Reference
100 tests
EMDN
W01021306
EMDN description
TROPONIN I/T
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
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
06978465237047
Basic UDI-DI
697846523ProteinC10RE
Reference
50 tests
EMDN
W01021306
EMDN description
TROPONIN I/T
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
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
06978465237030
Basic UDI-DI
697846523ProteinC10RE
Reference
25 tests
EMDN
W01021306
EMDN description
TROPONIN I/T
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Protein Induced by Vitamin K Absence or Antagonist-II 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
06978465236491
Basic UDI-DI
697846523TumorC029X
Reference
2×100 test
EMDN
W0102039017
EMDN description
PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Protein Induced by Vitamin K Absence or Antagonist-II 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
06978465236484
Basic UDI-DI
697846523TumorC029X
Reference
100 tests
EMDN
W0102039017
EMDN description
PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country
Austria
Authorised representative
HyperCert Limited B.V.
Last updated
30.06.2026 12:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details