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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 09:57

Sync status

Successful

Device

3606024

Actor

47872

Certificate

3406

Active filter:Manufacturer SRN:CN-MF-000047336

365 device results listed.

Page 11 / 19

CSVXML
06978465230383

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465230383
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 productsAuthorised representative productsAuthorised representative actorsView details
06978465230390

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465230390
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 productsAuthorised representative productsAuthorised representative actorsView details
06978465230406

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465230406
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 productsAuthorised representative productsAuthorised representative actorsView details
06978465230413

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465230413
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 productsAuthorised representative productsAuthorised representative actorsView details
06978465230420

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465230420
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 productsAuthorised representative productsAuthorised representative actorsView details
Thyroid 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
06978465230505
Basic UDI-DI
697846523HormoneB05HX
Reference
2×50 test
EMDN
W01020410
EMDN description
THYROID STIMULATING HORMONE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Total Triiodothyronine Assay kit(Chemiluminescence Immunoassay Method）

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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
06978465230604
Basic UDI-DI
697846523HormoneB01HP
Reference
2×50 test
EMDN
W01020405
EMDN description
TRIIODOTHYRONINE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Free Triiodothyronine 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
06978465230703
Basic UDI-DI
697846523HormoneB02HR
Reference
2×50 test
EMDN
W01020401
EMDN description
FREE TRIIODOTHYRONINE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Total Thyroxine 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
06978465230802
Basic UDI-DI
697846523HormoneB03HT
Reference
2×50 test
EMDN
W01020407
EMDN description
THYROXINE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Free Thyroxine 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
06978465230901
Basic UDI-DI
697846523HormoneB04HV
Reference
2×50 test
EMDN
W01020402
EMDN description
FREE THYROXINE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Thyroglobulin 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
06978465231007
Basic UDI-DI
697846523HormoneB06HZ
Reference
2×50 test
EMDN
W01020408
EMDN description
THYROGLOBULIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Antibody to thyroglobulin Assay kit(Chemiluminescence Immunoassay Method）

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IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN
CN-MF-000047336
UDI-DI
06978465231106
Basic UDI-DI
697846523autoAbsB01QN
Reference
2×50 test
EMDN
W0102100303
EMDN description
THYROGLOBULIN AUTOANTIBODY
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Antibodies to Thyroid Peroxidase 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
06978465231205
Basic UDI-DI
697846523autoAbsB02QQ
Reference
2×50 test
EMDN
W0102100301
EMDN description
THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Insulin 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
06978465231403
Basic UDI-DI
697846523HormoneB17J6
Reference
2×50 test
EMDN
W0102060103
EMDN description
INSULIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
C-Peptide 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
06978465231502
Basic UDI-DI
697846523HormoneB16J4
Reference
2×50 test
EMDN
W0102060101
EMDN description
C-PEPTIDE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
25-hydroxy Vitamin D 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
06978465231601
Basic UDI-DI
697846523VitaminB01LB
Reference
2×50 test
EMDN
W0102070206
EMDN description
VITAMIN D (CHOLECALCIFEROL)
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Vitamin B12 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
06978465231700
Basic UDI-DI
697846523VitaminB02LD
Reference
2×50 test
EMDN
W0102070204
EMDN description
VITAMIN B12
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Folate 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
06978465231809
Basic UDI-DI
697846523LipidsB01WN
Reference
2×50 test
EMDN
W0102070103
EMDN description
FOLATE
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
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
06978465231908
Basic UDI-DI
697846523HormoneB07J3
Reference
2×50 test
EMDN
W0102060312
EMDN description
PARATHYROID HORMONE INTACT
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Calcitonin 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
06978465232004
Basic UDI-DI
697846523ProteinB01R8
Reference
2×50 test
EMDN
W0102060301
EMDN description
CALCITONIN
First on market country
-
Authorised representative
HyperCert Limited B.V.
Last updated
16.06.2026 11:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details