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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

09.07.2026 14:28

Sync status

Successful

Device

2728732

Actor

47347

Certificate

3064

Active filter:Manufacturer SRN:CN-MF-000047336

365 device results listed.

Page 17 / 19

CSVXML
Thyroglobulin Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237573
Basic UDI-DI
697846523HormoneB06HZ
Reference
25 tests
EMDN
W01020408
EMDN description
THYROGLOBULIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Thyroglobulin Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237580
Basic UDI-DI
697846523HormoneB06HZ
Reference
50 tests
EMDN
W01020408
EMDN description
THYROGLOBULIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Thyroglobulin Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237597
Basic UDI-DI
697846523HormoneB06HZ
Reference
100 tests
EMDN
W01020408
EMDN description
THYROGLOBULIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Insulin Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237603
Basic UDI-DI
697846523HormoneB17J6
Reference
25 tests
EMDN
W0102060103
EMDN description
INSULIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Insulin Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237610
Basic UDI-DI
697846523HormoneB17J6
Reference
50 tests
EMDN
W0102060103
EMDN description
INSULIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Insulin Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237627
Basic UDI-DI
697846523HormoneB17J6
Reference
100 tests
EMDN
W0102060103
EMDN description
INSULIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
C-Peptide Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237634
Basic UDI-DI
697846523HormoneB16J4
Reference
25 tests
EMDN
W0102060101
EMDN description
C-PEPTIDE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
C-Peptide Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237641
Basic UDI-DI
697846523HormoneB16J4
Reference
50 tests
EMDN
W0102060101
EMDN description
C-PEPTIDE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
C-Peptide Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237658
Basic UDI-DI
697846523HormoneB16J4
Reference
100 tests
EMDN
W0102060101
EMDN description
C-PEPTIDE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Parathyroid Hormone Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237665
Basic UDI-DI
697846523HormoneB07J3
Reference
25 tests
EMDN
W0102060312
EMDN description
PARATHYROID HORMONE INTACT
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Parathyroid Hormone Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237672
Basic UDI-DI
697846523HormoneB07J3
Reference
50 tests
EMDN
W0102060312
EMDN description
PARATHYROID HORMONE INTACT
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Parathyroid Hormone Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237689
Basic UDI-DI
697846523HormoneB07J3
Reference
100 tests
EMDN
W0102060312
EMDN description
PARATHYROID HORMONE INTACT
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Human Chorionic Gonadotropin beta subunit Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237696
Basic UDI-DI
697846523HormoneB12HU
Reference
25 tests
EMDN
W0102050205
EMDN description
TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Human Chorionic Gonadotropin beta subunit Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237702
Basic UDI-DI
697846523HormoneB12HU
Reference
50 tests
EMDN
W0102050205
EMDN description
TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Human Chorionic Gonadotropin beta subunit Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237719
Basic UDI-DI
697846523HormoneB12HU
Reference
100 tests
EMDN
W0102050205
EMDN description
TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Luteinizing Hormone Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237726
Basic UDI-DI
697846523HormoneB14HY
Reference
25 tests
EMDN
W0102050105
EMDN description
LUTEINISING HORMONE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Luteinizing Hormone Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237733
Basic UDI-DI
697846523HormoneB14HY
Reference
50 tests
EMDN
W0102050105
EMDN description
LUTEINISING HORMONE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Luteinizing Hormone Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237740
Basic UDI-DI
697846523HormoneB14HY
Reference
100 tests
EMDN
W0102050105
EMDN description
LUTEINISING HORMONE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Follicle Stimulating Hormone Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237757
Basic UDI-DI
697846523HormoneB08J5
Reference
25 tests
EMDN
W0102050104
EMDN description
FOLLICLE STIMULATING HORMONE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Follicle Stimulating Hormone Assay kit(Chemiluminescence Immunoassay Method）

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465237764
Basic UDI-DI
697846523HormoneB08J5
Reference
50 tests
EMDN
W0102050104
EMDN description
FOLLICLE STIMULATING HORMONE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details