Manufacturer

Urit

ChinaLegal entities : URIT Medical Electronic Co.,Ltd.

First countries of placing on the market declared in EUDAMED : Germany, Italy, Poland, Spain

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

29 categories, 71 models including 71 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
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	BH-DR68 Diluent BH-DS68 Diluent BH-LD68 Lyse BH-LH68 Lyse BH-LN68 Lyse 9 others BH-LP68 Lyse URIT 5D 11 Diluent URIT D31、URIT 5D 11 URIT 5L 11 Lisante URIT 5L 31 Lyse URIT 5S 11 Sheath URIT D41 Detergent URIT D41、URIT D46 URIT D43 Probe Cleaner URIT D48 DI Probe Cleaner URIT L21 Lytic Reagent	A IVDR	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	BH-40P Automated Hematology Analyzer BH-40P、BH-70P BH-5100 5-Part-Diff Auto Hematology Analyzer URIT-5160、BH-5100 、BH-5390 BH-5160CRP 5-Part-Diff Auto Hematology Analyzer BH-5380CRP、BH-5160CRP、BH-5160CS BH-51S 5-Part-Diff Auto Hematology Analyzer98/79 BH-5360CRP 5-Part-Diff Auto Hematology Analyzer98/79 4 others BH-7000、BH-7010、BH-7020、BH-7030、BH-7060、BH-7080 Automatic Hematology Analyzer98/79 BH-7100H/BH-7160CS/BH-7160/BH-7180CS/BH-7180 Automatic Hematology Analyzer BH-7100H、BH-7160CS、BH-7160、BH-7180CS、BH-718098/79 URIT-5380 5-Part-Diff Auto Hematology Analyzer98/79 URIT-5500 5-Part-Diff Auto Hematology Analyzer98/79	B IVDR, 98/79	EUDAMED record Report an error
Normal blood controls	W0103010501	HQ-3DIFF HEMATOLOGY CONTROLS98/79 HQ-5DIFF HEMATOLOGY CONTROLS98/79 HQ-6D HEMATOLOGY CONTROLS98/79 URIT HQ 51 Hematology Control URIT HQ 60 Hematology Control 1 other URIT QC 11 Hematology Control	B IVDR, 98/79	EUDAMED record Report an error
Chemistry analysers - consumables	W0201010185	Detergent for Electrolyte Analyzer URIT-DC1 URIT-DC3 URIT-DC4	A IVDR	EUDAMED record Report an error
Urinary sediment devices	W0201010202	LaserVision Urine Sediment Analyzer UD-2300,UD-2310 ,UD-233098/79 UD-2300 UD-500、URIT-1280、UD-1320、UD-1300 US-1680、US-500、US-1000	B IVDR, 98/79	EUDAMED record Report an error
Automated whole blood hematology analysers - moderate routine (throughput > 100 and <= 120 samples/hr)	W0202010102	BH-6180 5-Part-Diff Auto Hematology Analyzer BH-6180、BH-6580、BH-6680、BH-6600、BH-6500、BH-6100 BH-7200H/BH-7260CS/BH-7260/BH-7280CS/BH-7280/ BH-7300H/ BH-7360CS/ BH-7360/BH-7380CS/BH-7380 Automatic Hematology Analyzer BH-7200H、BH-7260CS、BH-7260、BH-7280CS、BH-7280、BH-7300H、BH-7360CS、BH-7360、BH-7380CS、BH-738098/79 BH-7600CS、BH-7610CS、 BH-7620CS、BH-7630CS、 BH-7660CS、 BH-7680CS、BH-7680、BH-7600 5-Part-Diff Auto Hematology Analyzer98/79	B IVDR, 98/79	EUDAMED record Report an error
Specific reticulocyte reagents	W0103010102	BH-FP68 Fluorescent dye BH-FR68 Fluorescent dye URIT R11 Soluzione colorante per analizzatore ematologico	A IVDR	EUDAMED record Report an error
Automated 3 part hematology analysers	W0202010201	URIT-2900Plus Automated Hematology Analyzer98/79 URIT-3000Plus Automated Hematology Analyzer URIT-3000Plus、URIT-3020	B IVDR, 98/79	EUDAMED record Report an error
Automated urine analysers - consumables	W020101020185	Detergent for Automatic Urine Analyzer URIT D 21N、URIT D 22、UNAMAX D212 refs Maintenance agent for Urine Analyzer URIT D 22 、UNAMAX D222 refs	A IVDR	EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	CA-150 Automatic Chemistry Analyzer URIT-8031、URIT-8210、URIT-8400、URIT-8460、CA-220、CA-431A、CA-431B、CA-200、CA-641A、CA-641B、CA-641C、CA-150、CA-160、CA-180、CA-351A、CA-351B、CA-351C、CA-431C、URIT-8060、URIT-8030、URIT-8121A、URIT-8131、URIT-8136、CA-331A,etc CA-80 Semi-auto Chemistry Analyzer CA-80、URIT-880	A IVDR	EUDAMED record Report an error
Cytochemical staining reagents	W01030702	Staining Solution for Urine Analysis UFL-61 Staining Solution for Urine Analysis UFL-70、UFL-60	A IVDR	EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other	W0103010199	BH-FD68 Fluorescent dye BH-FN68 Fluorescent dye	A IVDR	EUDAMED record Report an error
Whole blood calibrators	W0103010507	HQ-CAL HEMATOLOGY CALIBRATOR98/79 URIT CA 11 Hematology Calibrator	B IVDR, 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	IA-200	A IVDR	EUDAMED record Report an error
Automated slide stainers	W0202059002	MP-1200、MP-1200B	A IVDR	EUDAMED record Report an error
Automated urine analysers	W020101020103	UC-1800、URIT-1600、UNAMAX2 refs	A IVDR	EUDAMED record Report an error
Auxiliary & supplemental reagents for flow cytometry - other	W0103080599	URIT RFP	A IVDR	EUDAMED record Report an error
Blood glucose meters	W0201060102	URIT-25,URIT-26,URIT-28,URIT-82,URIT-8698/79	– 98/79	EUDAMED record Report an error
Cell counting instruments - other	W02020199	BM-200 Automated Cell Morphology Analyzer BM-200、BM-200P98/79	– 98/79	EUDAMED record Report an error
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800)	W0201010102	CA-430A Automatic Chemistry Analyzer URIT-8460、CA-430A、CA-430B、CA-810A、CA-640A、CA-640B、URIT-8280、CA-810B、CA-810C	A IVDR	EUDAMED record Report an error
Cytoflowmeters - high routine	W0202040103	BF-730 B4 Flow Cytometer BF-730 B5R3V6、BF-730 B5R3V5、BF-730 B4R3V3、BF-730 B5R3、BF-730 B5R2、BF-730 B4R2、BF-730 B5、BF-730 B4、BF-700 B3R1、BF-700 B4、BF-700 B4R1、BF-700 B5、BF-700 B4R2、BF-700 B5R2、BF-700 B5R3、BF-710 B5R3、BF-710 B5R2、BF-710 B5 etc.	A IVDR	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Assay Kit (Chemiluminescent Microparticle Immunoassay)98/79	– 98/79	EUDAMED record Report an error
Glycosilated hemoglobin devices	W0201060101	URIT-12,PH-01,PH-01A98/79	– 98/79	EUDAMED record Report an error
Haematology standards and calibrators - RT & POC	W0103010607	Reticulocyte Calibrator URIT CA 3198/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	Interluekin-6 (IL-6) Assay Kit (Chemiluminescent Microparticle Immunoassay)98/79	– 98/79	EUDAMED record Report an error
Reticulocyte controls	W0103010506	URIT QC 31 Reticulocyte Control	B IVDR	EUDAMED record Report an error
Semi-automated coagulometers	W0202020101	URIT-600/ URIT-610 Coagulation Analyzer URIT-600、URIT-61098/79	– 98/79	EUDAMED record Report an error
Semi-automated urine analysers	W020101020102	URIT-31、UC-32A、UC-32B、URIT-50、URIT-180、URIT-330、URIT-500、URIT-500C、URIT-560、UC-58、UC-280A、UC-280B、UC-600A、UC-50A、UC-50B、UC-50C、UNAMAX ONE、UNAMAX LITE3 refs	A IVDR	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	PFS-30,PFS-30A98/79	– 98/79	EUDAMED record Report an error

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