Wondfo POCT Quantitative Detection Family

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1 Wondfo POCT Quantitative Detection Family POCT SOLUTION GUANGZHOU WONDFO BIOTECH CO., LTD.

2 ENTERPRISE INTRODUCTION Guangzhou Wondfo Biotech Co., Ltd., located in Guangzhou, China, is a globally recognized fast growing POCT manufacture and sales of rapid diagnostic reagents and related equipment in IVD (in vitro diagnostic) field. Founded in 1992, the company is continually expanding its scale. Apart from the Guangzhou headquarters, Wondfo also owns one overseas lab in San Diego, one branch in Chicago and other eleven overseas offices. Wondfo went public in June, 2015 (Stock Number: ), and has more than 1, 300 employees with 30% of them obtained postgraduate degrees. As one of the earliest high-tech biological companies focusing on rapid diagnostics for toxicology, infectious diseases, fertility, cardiovascular disease, tumor, respiratory disease, renal injury and diabetes, Wondfo has won good reputation around the world. In addition, Wondfo has got CE certificates, FDA certificates, FSC certificates, ISO 9001:2008 and ISO 13485:2012 quality system certification. We are dedicated to making the world a better place by providing people with high quality products and services.

3 Guangzhou Wondfo Biotech Co., Ltd.

4 PRODUCTS POCT Family

5 series FIA Meter CFDA Finecare TM Ⅱ FIA Meter Finecare TM Plus FIA Meter Finecare TM Ⅲ FIA Meter Wondfo Biotech 01

6 series FIA Meter Finecare TM FIA Meter is a fluorescence immunochromatographic analysing system which can help diagnose conditions such as infection, diabetes, cardiovascular diseases, renal injury and cancers, etc. The Finecare TM platform provides reliable and quantitative results of various kinds of analytes in human blood or urine within several minutes. Test Item Fertility β-hcg Infection PCT, CRP (hscrp+crp), 2 in 1 (CRP+PCT), SAA Cardiac NT-proBNP, ctni, Myo, CK-MB, H-FABP, 3 in 1 (ctni + Myo + CK-MB), 2 in 1 (ctni+nt-probnp), BNP Diabetes & Renal Injury HbA1c, MAU, CysC, NGAL, β2-mg Tumor AFP, PSA, CEA, fpsa Coagulation D-Dimer Hormone T3, T4, TSH Ongoing Vitamin-D, Progesterone, S100β, ST2, Lp-PLA2, PAPP-A, LH, FSH Features / Portable / Instant result / Expansive menu / High accuracy / Built-in printer / Self-calibration Principle Specimen Power adapter Interface Information input Printer Optical description Operating temperature Fluorescent immunochromatography Whole Blood/ Serum/ Urine AC, 50-60Hz RS232, USB, Ethernet (Direct connection to LIS / HIS) Touch screen, barcode reader Built-in thermal printer Excitation light source: LED, 470 nm / Detector: 525nm Photodiode Wondfo Biotech

7 Principle and Operation Mixing Sample Pad Wicking Pad Detection Zone IQC Zone Sampling Dropping Sample Pad Detection Zone IQC Zone Wicking Pad Reading Why Choose Finecare Extra quick operating platform for large number of specimens Unique quick mode Designed sampler Specially-designed sampler for small volume of specimen Information management High accuracy BRAHMS PCT(ng/ml) Y BRAHMS = X wondfo R 2 =0.988 n = Finecare TM FIA Meter(PCT ng/ml) Powerful information management (Direct connection to LIS/HIS) Instant result Room temperature storage Good correlation with wet chemistry method Convenient and fast. Get results in 3-utes Solid synthetic craft, can be stored at room temperature (4-30 ) Wondfo Biotech 03

8 Test Item Product Class Test Item Diseases Specimen Type Reaction Time Linear Range Clinical Reference Qualification Infection PCT CRP (hscrp+crp) 2 in 1 (CRP+PCT) SAA Sepsis Inflammation Infection & Inflammation Infection & Inflammation ng/ml ng/ml 3 min mg/l CRP:0-10 mg/l hscrp:0-1 mg/l CRP: mg/l CRP:<10 mg/l PCT: ng/l PCT:<0.5 ng/l mg/l 0-10 mg/l CE Coagulation D-Dimer Thrombosis WB/Plasma 5 min mg/l mg/l Cardiac NT-proBNP Heart Failure <75y, pg/ml pg/ml 75y, pg/ml ctni Myocardial Infarction ng/ml ng/ml Myo Myocardial Infarction ng/ml 0-58 ng/ml CK-MB Myocardial Infarction ng/ml 0-5 ng/ml H-FABP Myocardial Infarction ng/ml 0-7 ng/ml 3 in 1 Myocardial Same with Same with (ctni/ Myo Infarction single items single items / CK-MB) BNP Heart Failure WB pg/ml pg/ml CE 2 in 1 (ctni/ NT-proBNP) Myocardial Infarction Same with single items Same with single items CE Tumor Diabetes & Renal Injury AFP Liver Cancer Serum ng/ml 0-20 ng/ml PSA Prostate Cancer Serum ng/ml 0-4 ng/ml CEA Cancer ng/ml 0-5 ng/ml HbA1c Diabetes Mellitus WB 5 min % 4-6% MAU Renal Injury Urine 3 min mg/l 0-20 mg/l CysC Renal Injury 5 min mg/l mg/l NGAL Renal Injury Urine ng/ml ng/ml β2-mg Proximal Renal Tubule Dysfunction 10 min mg/l mg/l CE CE CE IFCC NGSP CE CE Fertility β-hcg Fertility 2-200,000 miu/ml 5 miu/ml Hormone T3 T4 TSH Thyroid Malfunction Thyroid Malfunction Thyroid Malfunction nmol/l nmol/l miu/l nmol/l nmol/l miu/l CE CE 04 Wondfo Biotech

9 TM T3, T4, TSH Hormone Disorder Markers Thyroid gland is the largest gland in the human body. It regulates energy metabolism in cells and organs. The thyroid gland produces hormones thyroxine (T4) and triiodothyronine (T3), which are vital in regulating the metabolism. Production of these hormones is stimulated by the thyroid stimulating hormone (TSH), the anterior pituitary gland hormone. Parameters of Finecare TM T3, T4, TSH test Items T3, T4, TSH Detection principle Fluorescence immunoassay Sample type Whole blood/serum/plasma TM Sample capacity 75 μl for one test Content: >25 Test Cassettes >1 ID Chip >1 Instruction Manual Reaction time Test time utes for one test 10 seconds for one test TSH comparision test between Wondfo and Roche 40 Wondfo(mIU/L) y = x R² = N= Roche(mIU/L) TSH comparision test between Wondfo and Roche has a good clinical correlation. Recommended Reference Items T3 T4 TSH Detection Range 0.61~9.22 nmol/l 12.87~300 nmol/l 0.1~100 miu/l Normal Range 1.3~3.1 nmol/l 66~181 nmol/l 0.3~4.2 miu/l Clinical application Source of pathology T3, T4 level TSH level Disease causing conditions Hypothalamus/pituitary High High Benign tumor of the pituitary (adenoma) or thyroid hormone resistance Hypothalamus/pituitary Low Low Secondary hypothyroidism or "central" hypothyroidism Hyperthyroidism High Low Primary hyperthyroidism i.e. Graves' disease Hypothyroidism Low High Congenital hypothyroidism (cretinism), Primary hypothyroidism i.e. Hashimoto's thyroiditis Wondfo Biotech 05

10 TM CRP Infection Markers The C-reactive protein (CRP) is synthesized by the liver in response to interleukin-6 and is well known as one of the classical acute-phase reactants. It is used as a marker of inflammation and cardiovascular diseases (CVD). Parameters of Finecare CRP test Detection object CRP Specimen type WB / Serum Specimen capacity 8.5 μl / 5 μl / 5 μl TM Reaction time 3 minutes Content: >25 Test Cassettes >1 ID Chip >1 Instruction Manual Test time 10 seconds Linear range mg/l Clinical reference CRP:0-10 mg/l / hscrp:0-1mg/l Capillary tube for CRP Performance of CRP Rapid Quantitative Test Finecare TM FIA Meter y = x R 2 = Specially-designed capillary tube for kids and babies; convenient sampling, useful in Pediatrics, ER and ICU. DN-100 Special Protein Analyzer Compared with CRP results of 417 specimens from DN-100 Special Protein Analyzer, Wondfo Finecare FIA system has high accuracy in CRP test (R 2 >0,98). 06 Wondfo Biotech

11 TM PCT Infection Markers PCT Procalcitonin is a peptide precursor of the hormone calcitonin. Measurement of PCT can be used as a authoritative marker for diagnosis and stratification of sepsis. Parameters of Finecare PCT test Detection object PCT Specimen type WB / Serum Specimen capacity 75 μl / 50 μl / 50 μl TM Reaction time Test time utes 10 seconds Content: >25 Test Cassettes >1 ID Chip >1 Instruction Manual Linear range ng/ml Clinical reference ng/ml Performance of Finecare PCT Rapid Quantitative Test B.R.A.H.M.S PCT LIA Compared with PCT results of 417 specimen from B.R.A.H.M.S PCT LIA, Wondfo Finecare FIA system has high accuracy in PCT test (R 2 >0.98) Y BRAHMS = X wondfo R 2 =0.988 n = Wondfo Finecare TM PCT Finecare Test Procedure Sampling Mixing Dropping Reading Wondfo Biotech 07

12 HbA1c/MAU/CysC Diabetes and Renal Injury Markers Diabetes and Diabetic Nephropathy (DN) are urgent and growing problems of the world, and that causes high and escalating costs to the society. In 2014, an estimated 387 million people have diabetes worldwide. From 2012 to 2014, diabetes is estimated to have resulted in 1.5 to 4.9 million deaths each year. WHO projects that diabetes will be the 7th leading cause of death by WORLD 592M People living with diabetes in % WORLD 387M AFR 109.1% MENA 96.2% increase SEA 70.6% SACA 59.8% WP 46% NAC 37.3% EUR 22.4% IDF chairman--- Professor Jean Claude Manbaya said: "Diabetes caused 5.1 million deaths in Every six seconds a person dies from diabetes". Diabetes and Renal Injury Markers HbA1c : HbA1c is the product of the hemoglobin combining with blood glucose in red blood cells, which can reflect the average blood glucose level over the preceding 2-3 months. MAU (Microalbumin) : It occurs when the kidney leaks small amounts of albumin into the urine, which is an early markers of kidney damage. CysC : CysC is the inhibitor of cysteine proteinases, and the level of CysC indicates the stage of kidney diseases. Parameters of Finecare Diabetes and Renal Injury Tests Test item Diseases Specimen type Specimen capacity Reaction time Linear range Clinical reference HbA1c Diabetes Mellitus WB 10 μl 5 min % 4-6% CysC Renal Injury WB/Serum/Plasma 10 μl/10 μl/10 μl 5 min mg/l mg/l MAU Renal Injury Urine 75 μl 3 min mg/l 0-20 mg/l 08 Wondfo Biotech

13 Performance of Finecare Diabetes and Renal Injury Tests Performance comparison: Wondfo vs Bio-Rad, Orion and Randox HbA1c Bio-Rad D Cutoff value: 6.5% Specimen : Whole blood 10 μl Reaction time: 5 min y=0.9888x R 2 = n= Wondfo Comparison between Wondfo One step HbA1c quantitative test kit and Bio-Rad HbA1c. The clinical correlation result (R 2 =0.9702) meets the clinical requirement. MAU Cutoff value: < 20mg/L Specimen : Urine 75 μl Reaction time: 3 min Wondfo (mg/l) y=0.975x R 2 = Orion QuikRead (mg/l) Comparison between Wondfo-MAU Quantitative Test Kit and QuikRead-MAU. The clinical correlation result (R 2 =0.9774) meets the clinical requirement. CysC Specimen: Whole blood/serum/plasma 10 μl Reaction time: 5 min Wondfo(mg/L) Level of renal injury Mild renal injury Moderate renal injury Serious renal injury Uremia y=0.9756x R 2 = CysC Value (mg/l) 0.95<CysC< <CysC< <CysC<3.2 CysC> Randox(mg/L) Comparison between Wondfo CysC Quantitative Test Kit and Randox CysC (Immunoturbidimetry assay, trace back IFCC). The clinical correlation result (R 2 =0.9691) meets the clinical requirement. Finecare Test Procedure Specially-designed capillary tube for HbA1c Mixing Sampling Dropping Reading Wondfo Biotech 09

14 TM ctni/h-fabp/nt-probnp/ck-mb/myo/3 in 1/2 in 1/BNP Cardiac Markers Cardiac markers are used in the diagnosis and risk stratification of patients with chest pain, suspected Acute Coronary Syndrome (ACS) and Heart Failure (HF). Parameters of Finecare Cardiac Markers Test items Specimen types Specimen capacity Reaction time Linear range Clinical significance NT-proBNP WB/Serum/Plasma 75 μl/75 μl/75 μl pg/ml 75 years old: 300 ng/l, 75 years old: 450 ng/l: Indicating risk of congestive heart failure ctni WB/Serum/Plasma 75 μl/75 μl/75 μl ng/ml >0.3 ng/ml: High risk of MI CK-MB WB/Serum/Plasma 75 μl/75 μl/75 μl ng/ml >5 ng/ml: High risk of MI Myo WB/Serum/Plasma 75 μl/75 μl/75 μl ng/ml >58 ng/ml: High risk of MI H-FABP WB/Serum/Plasma 75 μl/75 μl/75 μl ng/ml 7 ng/ml: High risk of MI, combined with other clinical data Whole range CRP WB/Serum/Plasma 8.5 μl/5 μl/5 μl 3 min mg/l hscrp<1mg/l Low CVD risk hscrp mg/l Moderate CVD risk hscrp 3.0 mg/l High CVD risk CRP 10 mg/l Infection or inflammation 3 in 1 (ctni/ck-mb/myo) WB/Serum/Plasma 75 μl/75 μl/75 μl Same with single items ctni<0.3 ng/ml & CK-MB<5 ng/ml & Myo<58 ng/ml: initial exclusion of MI 2 in 1 (ctni/nt-probnp) WB/Serum/Plasma 75 μl/75 μl/75 μl Same with single items Same with single items BNP WB/Plasma 75 μl/75 μl pg/ml pg/ml Applications Cardiology Dept., EU, ICU, CCU and Operating Room Others: Laboratory, Respiratory Medicine, Cardiothoracic Surgery, Geriatric Hospital TM Content: >25 Test Cassettes >1 ID Chip >1 Instruction Manual 10 Wondfo Biotech

15 For cardiac markers testing, time means life Finecare Test Procedure Performance of Finecare Cardiac Markers Rapid Quantitative Test Mixing Roche y=0.9888x R 2 = n=483 Sampling Dropping Wondfo (CK-MB) Reading Performance comparison between Finecare FIA Rapid Quantitative Test system and Roche shows Finecare TM has high accuracy (R 2 >0.98), which can satisfy the clinical requirement. Signification of Combined Diagnosis h-fabp ctni Diagnosis suggestion of myocardial injury markers Concentration MYO CK-MB 2h H-FABP+Myo 2-6h H-FABP+Myo+cTnI+CK-MB 4-8h ctni+ck-mb Normal level 8h ctni The markers concentration after AMI (h) Early diagnosis of AMI Risk assessment, stratification and prognosis of ACS Early judgment of ACS Therapeutic decision-making of ACS Estimation of Myocardial Infarct Size Wondfo Biotech 11

16 D-Dimer Coagulation Markers D-Dimer is a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. It is useful in the diagnostic evaluation of thrombotic diseases. Parameters of Finecare D-Dimer test Performance of D-Dimer Detection object Specimen type Specimen capacity D-Dimer Whole blood 15 μl / 10 μl Comparison test of D-Dimer whole blood specimen between Wondfo and Siemens y=0.9844x R 2 = Reaction time Test time 5 minutes 10 seconds Wondfo (mg/l) Siemens (mg/l) Compared with 365 test results of D-Dimer specimens conducted by Siemens, Wondfo Finecare, shows good correlation. (R 2 = ) Clinical Application Clinical significance: Efficiency of clinical diagnosis, treatment and diagnosis pathway can be optimized based on the following 3 aspects: D-Dimer screening during clinical early phase (disease with symptoms of dizziness, chest pain and dyspnea, MI, pulmonary embolism, cerebral infarction, etc.), treatment evaluation (MI, cerebral infarction, etc.), monitoring and prognosis of chronic diseases (Tumor). Pathway 1 Dizziness Chest pain Dyspnea Screening Screening D-Dimer 0.5mg/L Pulmonary embolism Cerebral infarction MI D-Dimer 0.5mg/L Confirm Negative Thrombolysis Other tests (PCT/CRP) Appropriate dosage: D-Dimer level increase then decrease until normal. Inappropriate dosage: D-Dimer level increases then remains still or slowly decreases. Pathway 2 Dizziness Chest pain Dyspnea Routine Monitoring Differentiating tumor stage Routine Monitoring Tumor prognosis, management of life quality 12 Wondfo Biotech

17 TM β-hcg Fertility Human chorionic gonadotropin (HCG) is a kind of hormone, produced by the developing placenta shortly after conception. It s made up of α-and β-glycoprotein dimers, and its β subunit is used for early detection of pregnancy. Parameters of Finecare β-hcg test Detection object β-hcg Performance Evaluation of β-hcg quantitative test Specimen type Whole blood / Serum Abbott VS Wondfo Specimen capacity Reaction time Test time Linear range Clinical reference 20 μl / 20 μl / 20 μl utes 10 seconds 2-200,000 miu/ml 5 miu/ml Finecare TM β-hcg Rapid Quantitative Test can detect tiny amounts of this hormone in blood. Abbott HCG measured value (miu/ml) y=1.0552x R 2 = Wondfo HCG measured value (miu/ml) Application HCG level trend in pregnancy under different conditions HCG level in pregnancy Trophoblast disease HCG clinical value Early diagnosis for pregnancy Early diagnosis for ectopic pregnancy HCG level (mlu/ml) Ectopic Pregnancy Normal pregnancy Efficacy evaluation for conservative treatment of ectopic pregnancy Auxiliary diagnosis for miscarriage Auxiliary diagnosis and efficacy evaluation for gestational trophoblastic diseases 0 Miscarriage Gestational week TM Content: >25 Test Cassettes >1 ID Chip >1 Instruction Manual Wondfo Biotech 13

18 TM AFP Tumor Markers AFP (Alpha-fetoprotein) is a major plasma protein produced by yolk sac and liver during fetal development. It is widely used to detect a subset of tumors in non-pregnant women, men and children. Parameters of Finecare AFP test Detection object AFP TM Specimen type Serum Content: >25 Test Cassettes >1 ID Chip >1 Instruction Manual Specimen capacity Reaction time 75 μl utes Test time 10 seconds Comparison of AFP tests between Wondfo and Roche Wondfo-AFP y=1.0004x R 2 = Roche-AFP Compared with 629 test results of AFP specimens conducted by Roche, Wondfo Finecare FIA System has high accuracy in AFP test. Correlation(R 2 =0.9945) can satisfy the clinical requirement. 14 Wondfo Biotech

19 TM PSA Tumor Markers PSA (Prostate Specific Antigen) is a protein produced by cells of prostate gland, which is a biomarker for screening prostate cancer. It is also widely used for monitoring the recurred prostate cancer after initial treatment. Parameters of Finecare PSA test Detection object PSA Comparison of PSA tests between Wondfo and Roche Specimen type Specimen capacity Reaction time Test time Serum 75 μl utes 10 seconds Wondfo-PSA y=0.9997x R 2 = Roche-PSA Advanced methodology Immunofluorescence technology Simple operation 4 steps ( sampling, mixing, dropping, reading ) Compared with 829 test results of PSA specimens conducted by Roche, Wondfo Finecare FIA System has high accuracy in PSA test. Correlation (R 2 =0.994) can satisfy the clinical requirement. High accuracy IQC/EQC double quality control Authorized certification CE TM Wondfo Finecare provides you with fast, convenient, accurate, and reliable tumor markers quantitative rapid test as well as powerful information management. Content: >25 Test Cassettes >1 ID Chip >1 Instruction Manual Wondfo Biotech 15

20 1 Vial TM Controls Wondfo Controls are intended as an assayed quality control to monitor the precision of laboratory testing procedures for the analytes listed in the following table. Product Class Cat. No. Test Item Level Specification Storage Temperature Shelf Life Qualification W806-L/W806-M/W806-H CRP 12 months Infection W805-L/W805-N/W805-H PCT 12 months W818-L/W818-M/W818-H CRP-PCT 12 months W810-L/W810-N/W810-H CK-MB 18 months W809-L/W809-N/W809-H Myo 12 months Cardiac W808-L/W808-N/W808-H W817-L/W817-M/W817-H ctni ctni/ck-mb/myo 12 months 12 months W811-L/W811-N/W811-H H-FABP 12 months W807-L/W807-N/W807-H NT-proBNP 12 months Tumor W815-L/W815-M/W815-H W814-L/W814-M/W814-H AFP PSA 8 months 12 months Diabetes & W813-L/W813-N/W813-H MAU 18 months Renal Injury W816-L/W816-M/W816-H CysC 12 months Fertility W819-L/W819-M/W819-H β-hcg 12 months Coagulation W812-L/W812-N/W812-H D-Dimer 12 months Ongoing: T3, T4, TSH TM For in vitro diagnostic use only. For professional use only. Contents: 1. Control (lyophilized): 0.5mL 1 2.Leaflet with instruction for use Guangzhou Wondfo Biotech Co., Ltd. No. 8 Lizhishan Road, Science City, Luogang District, Guangzhou, Guangdong, P.R. China Tel: Fax: Finecare@wondfo.com.cn 16 Wondfo Biotech

21 Blood Glucose Monitoring System 400 USA Technology 400 Memories Fast Test Less Blood Sample Automatic Temperature Adjust Storage: 825 W 75th St, Unit B Willowbrook IL E C REP Qarad b.v.b.a. Volmolenheide 13 Blood Glucose Monitoring System 200 USA Technology 200 Memories Fast Test Less Blood Sample Automatic Temperature Adjust Storage: 825 W 75th St, Unit B Willowbrook IL E C REP Qarad b.v.b.a. Volmolenheide 13 Blood Glucose Monitoring System 100 USA Technology 100 Memories Fast Test Less Blood Sample Automatic Temperature Adjust Storage: 825 W 75th St, Unit B Willowbrook IL E C REP Qarad b.v.b.a. Volmolenheide 13 Glucose Meter The Extracare series blood glucose monitoring system is designed to measure the blood glucose levels in fresh fingertip blood. The system is suitable for diabetics to monitor their blood glucose level at home by themselves and also can be used at clinical sites by healthcare professionals. Test sample Test time Sample volume Hematocrit range Storage temperature Operating temperature Operating relative humidity Memory capacity Power supply Battery life Dimension and weight Capillary Whole Blood about 10 sec 0.8 μl 30 50% -20 ~ <85% 400 most recent results 3-Volt lithium battery (CR-2032) Approximately 1000 tests mm; 50g Extracare Series Blood Glucose Monitoring System 1x Meter + 25x Strips Blood Glucose Monitoring System Store the meter, control solution, test strips unde room temperature. Operation Temperature:10-40 Please read user's manual carefully before testing. This product is suitable for self-testing. Authorized Distributor: Manufactured for Wondfo USA Co., Ltd B-2400 Mol, Belgium 1x Meter + 10x Strips Blood Glucose Monitoring System Store the meter, control solution, test strips unde room temperature. Operation Temperature:10-40 Please read user's manual carefully before testing. This product is suitable for self-testing. Authorized Distributor: Manufactured for Wondfo USA Co., Ltd B-2400 Mol, Belgium 1x Meter Blood Glucose Monitoring System Store the meter, control solution, test strips unde room temperature. Operation Temperature:10-40 Please read user's manual carefully before testing. This product is suitable for self-testing. Authorized Distributor: Manufactured for Wondfo USA Co., Ltd B-2400 Mol, Belgium Customized Glucose Monitoring System is also available. Wondfo Biotech 17

22 OUR VISION Provide professional product and service of rapid diagnosis and chronic disease management; pursue better and convenient user experience; promote high-standard life and health quality; fulfill shared dream of our staff, customers and partners. Istanbul London Frankfurt Moscow Bucharest Chicago Branch Abuja Guangzhou San Diego Lab Nairobi Delhi Cape Town Jakarta Manila Belo Horizonte 1 Overseas Lab 1 Branch 12 Overseas Offices

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24 Guangzhou Wondfo Biotech Co., Ltd. Add: No. 8 Lizhishan Road, Science City, Luogang District, , Guangzhou, P.R. China Tel: Fax: sales@wondfo.com.cn Websites: Version

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