Manufacturer

Shenzhen Drawray Biotech

ChinaLegal entities : Shenzhen Drawray Biotech Co., Ltd.

Markets : Netherlands · Spain

Approvals : EU – class A, C

EU representative : Lotus NL B.V. (Netherlands)

Website info@szdrawray.com

12 categories, 45 models including 45 on the market, 1 country

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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
D-dimer	W0103020503	30 Tests/kit D-Dimer 20 tests/kit98/79 D-Dimer 5 tests/kit98/79 iStar-D-dimer 30 Tests98/79 iStar-D-dimer Ⅱ 25 Tests/kit98/79 5 others iStar-D-dimer Ⅱ 2×25 Tests/kit98/79 iStar-D-dimer Ⅱ 2×50 Tests/kit98/79 iStar-D-dimer Ⅱ 30 Tests/kit98/79 Unicorn-D-dimer 20 Tests/kit98/79 Unicorn-D-dimer 5 Tests/kit98/79	C IVDR, 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	5 Tests/kit 20 Tests/kit2 refs iStar-IL-6 30 Tests98/79 iStar-IL-6 Ⅱ 25 Tests/kit98/79 iStar-IL-6 Ⅱ 2×25 Tests/kit98/79 iStar-IL-6 Ⅱ 2×50 Tests/kit98/79 3 others iStar-IL-6 Ⅱ 30 Tests/kit98/79 Unicorn-IL-6 20 Tests/kit2 refs98/79 Unicorn-IL-6 5 Tests/kit2 refs98/79	C IVDR, 98/79	EUDAMED record Report an error
Coagulation inhibitors - other	W0103020699	iStar-TM 25 Tests/kit98/79 iStar-TM 2×25 Tests/kit98/79 iStar-TM 2×50 Tests/kit98/79 iStar-TM 30 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	iStar-FDP 25 Tests/kit98/79 iStar-FDP 2×25 Tests/kit98/79 iStar-FDP 2×50 Tests/kit98/79 iStar-FDP 30 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Plasmin - a2 - antiplasmin complex	W0103020305	iStar-PIC 25 Tests/kit98/79 iStar-PIC 2×25 Tests/kit98/79 iStar-PIC 2×50 Tests/kit98/79 iStar-PIC 30 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Plasminogen activator-inhibitors	W0103020506	iStar-t-PAIC 25 Tests/kit98/79 iStar-t-PAIC 2×25 Tests/kit98/79 iStar-t-PAIC 2×50 Tests/kit98/79 iStar-t-PAIC 30 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Thrombin-antithrombin III-complex	W0103020307	iStar-TAT 25 Tests/kit98/79 iStar-TAT 2×25 Tests/kit98/79 iStar-TAT 2×50 Tests/kit98/79 iStar-TAT 30 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	UC1-A UC1-B2 refs UC10 UC100	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - consumables	W0201020185	96 pcs/rack, 20 racks/box	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	iStar 500	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	iStar 2000-A/ iStar 2000-B/ iStar 2000-C3 refs	A IVDR	EUDAMED record Report an error
Samples analyses, plastic cuvettes	W0503010203	1000 pcs/bag,2 bags/box	A IVDR	EUDAMED record Report an error

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