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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

24.09.2026 00:27

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Successful

Device

3604189

Actor

47851

Certificate

3404

Active filter:Manufacturer SRN:CN-MF-000047336

365 device results listed.

Page 12 / 19

CSVXML
Ferritin Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465232103
Basic UDI-DI
697846523ProteinB02RA
Reference
2×50 test
EMDN
W0102070102
EMDN description
FERRITIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Procalcitonin Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465233001
Basic UDI-DI
697846523ProteinB03RC
Reference
2×50 test
EMDN
W0102069013
EMDN description
PROCALCITONIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Interleukin-6 Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465233100
Basic UDI-DI
697846523OtherB02YQ
Reference
2×50 test
EMDN
W01030609
EMDN description
INTERLEUKIN 6 (IL-6)
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Serum Amyloid A protein Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465233209
Basic UDI-DI
697846523ProteinB04RE
Reference
2×50 test
EMDN
W01021199
EMDN description
RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Pepsinogen I Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465234305
Basic UDI-DI
697846523ProteinB05RG
Reference
2×50 test
EMDN
W0102069006
EMDN description
PEPSINOGEN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Pepsinogen II Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465234404
Basic UDI-DI
697846523ProteinB06RJ
Reference
2×50 test
EMDN
W0102069006
EMDN description
PEPSINOGEN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Gastrin-17 Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465234602
Basic UDI-DI
697846523ProteinB07RL
Reference
2×50 test
EMDN
W0102069001
EMDN description
GASTRIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Human Chorionic Gonadotropin beta subunit Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465234824
Basic UDI-DI
697846523HormoneB12HU
Reference
2×50 test
EMDN
W0102050205
EMDN description
TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Luteinizing Hormone Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465234923
Basic UDI-DI
697846523HormoneB14HY
Reference
2×50 test
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）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465235029
Basic UDI-DI
697846523HormoneB08J5
Reference
2×50 test
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
Prolactin Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465235128
Basic UDI-DI
697846523HormoneB15J2
Reference
2×50 test
EMDN
W0102050108
EMDN description
PROLACTIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Progesterone Assay kit(Chemiluminescence Immunoassay Method）

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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
06978465235227
Basic UDI-DI
697846523HormoneB11HS
Reference
2×50 test
EMDN
W0102050106
EMDN description
PROGESTERONE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Testosterone Assay kit(Chemiluminescence Immunoassay Method）

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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
06978465235326
Basic UDI-DI
697846523HormoneB13HW
Reference
2×50 test
EMDN
W0102050110
EMDN description
TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Estradiol Assay kit(Chemiluminescence Immunoassay Method）

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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
06978465235425
Basic UDI-DI
697846523HormoneB09J7
Reference
2×50 test
EMDN
W0102050103
EMDN description
ESTRADIOL
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Anti-Mullerian Hormone Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465235524
Basic UDI-DI
697846523HormoneB10HQ
Reference
2×50 test
EMDN
W0102050215
EMDN description
ANTI-MÛLLERIAN 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
N-terminal Peptide of Procollagen Type III Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465235562
Basic UDI-DI
697846523ProteinB08RN
Reference
50 tests
EMDN
W0102019099
EMDN description
SPECIFIC PROTEINS - OTHER
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
N-terminal Peptide of Procollagen Type III 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
06978465235579
Basic UDI-DI
697846523ProteinB08RN
Reference
2×50 test
EMDN
W0102019099
EMDN description
SPECIFIC PROTEINS - OTHER
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
N-terminal Peptide of Procollagen Type III 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
06978465235586
Basic UDI-DI
697846523ProteinB08RN
Reference
100 tests
EMDN
W0102019099
EMDN description
SPECIFIC PROTEINS - OTHER
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
N-terminal Peptide of Procollagen Type III 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
06978465235593
Basic UDI-DI
697846523ProteinB08RN
Reference
2×100 test
EMDN
W0102019099
EMDN description
SPECIFIC PROTEINS - OTHER
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Collagen Type IV Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465235616
Basic UDI-DI
697846523ProteinB09RQ
Reference
50 tests
EMDN
W0102120199
EMDN description
LIVER FUNCTION - OTHER
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details