Manufacturer

Shenzhen Dake Medical Technology

ChinaLegal entities : Shenzhen Dake Medical Technology Co.,Ltd

First countries of placing on the market declared in EUDAMED : Austria

EU representative : SUNGO Europe B.V. (Netherlands)

8 categories, 8 models including 8 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	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); etc2 refs	A IVDR	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Assay kit Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs	C IVDR	EUDAMED record Report an error
Fibrinolysis tests - other	W0103020599	Fibrin Degradation Product Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs	C IVDR	EUDAMED record Report an error
Glycosilated hemoglobin devices	W0201060101	Automatic Glycohemoglobin Analyzer Bright h600, Bright h600Pro, Bright h600Max, Bright h800, Bright h800Pro, Bright h800Max, Bright h1200, Bright h1200Pro, Bright h1200Max3 refs	A IVDR	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	Interleukin-6 Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs	B IVDR	EUDAMED record Report an error
Plasminogen activator-inhibitors	W0103020506	Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs	C IVDR	EUDAMED record Report an error
Thrombin-antithrombin III-complex	W0103020307	Thrombin-antithrombin Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs	B IVDR	EUDAMED record Report an error
Tissue plasminogen activator	W0103020507	Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs	C IVDR	EUDAMED record Report an error

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