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Page 1: Facilities - Vincent Medical
Page 2: Facilities - Vincent Medical

Hong Kong Corporation 港资企业China Operation 中国运营Global Facilitation 全球便利化Vincent Medical Mfg. Co., Ltd. is a Hong Kong company that manufactures various types of medical devices in its solely owned China factory. With offices in Hong kong, China and US, our platform serves leading multi-national medical device companies with our contract manufacturing services and market our own brand Inspired Medical respiratory and orthopaedics products to all over the world. 永胜医疗制品有限公司属港资企业,生产基地设在中国东莞,主要生产各类医疗制品,在香港、中国和美国均设有办事处。除了为全球领先的医疗设备企业提供代工服务, 还开发了自主品牌“ 英仕医疗 ”, 销售呼吸系统类产品和骨科康复类产品到世界各地 。

Our Advantages■ A turn-Key contract manufacturer of medical devices.■ Extensive experience serving U.S., Europe and Japan medical device leaders.■ Hong kong based company ensures integrity and clear communication.■ ISO9001 / ISO13485 / ISO11135 / EN550 / CE certified■ U.S.FDA / cFDA registered, compliance with GMP requirements.■ Strict internal quality control and compliance to documentation of customers.■ A strong and diversified engineering team with formally trained and experienced engineers.

我们的优势■ 提供一站式服务的医疗器材制造商。■ 拥有为美国、欧洲和日本领先的医疗设备企业服务的丰富经验。■ 港资企业, 注重诚信, 与客人沟通无障碍。■ 获得ISO9001/ ISO13485/ ISO1113/ EN550/ CE 认证证书。■ 已注册U.S.FDA/ cFDA, 符合GMP要求。■ 有严格的内部质量控制体系, 符合客户的文件控制标准。■ 拥有一个强大的工程团队, 工程师经过专业培训, 在不同领域 获得专业资格证, 经验丰富。

Facilities ■ Over 52,000 sq. m. facility on 60,000 sq. m. of land■ Cutting & sewing production■ Class 100,000 clean room■ White room class controlled room■ Plastic injection molding(80 to 360 Tons)■ Boot bonding line■ Ultrasonic, high frequency and heat welding ■ Metal stamping and die-cutting■ In-house injection mold construction workshop■ Electronic assembly■ Pad and silk screen printing■ Packaging, labeling, bar-coding■ Qualified EtO sterilization facility

厂房设施■ 工厂占地60,000平米, 厂房面积超过52,000平米■ 专业车缝生产车间■ 10万级的无尘车间■ 控制车间■ 10万级的塑胶注塑成形(80-360吨)车间■ 步行鞋底贴合生产线■ 超声焊、高周波焊和热焊生产车间■ 金属冲压和模切车间■ 室内注塑模制造和维修车间■ 电子组装车间■ 移印、丝印和喷油车间■ 包装、打标签、条形码车间■ 环氧乙烷灭菌设备(ETO 消毒炉)

Orthopaedics Brace and Medical Softgoods ProductionOur medical cutting and sewing production is ISO13485 qualified and experienced in a broad range of textile based sewn medical products.From simple one-time use items to post-operative bracing systems and physician order only for use restraints with demanding performance characteristics our cutting & sewing manufacturing capabilities include:■ Pattern and marker design control (by flatbed plotter & cutter)■ Cutting (Die cutting, table cutting, knife cutting, strip cutting, automatic cutting machine)

Page 3: Facilities - Vincent Medical

■ Sewing ( Binding, single straight stitching, double stitching, bar tacking, overlocking, zigzag stitching, quilting,button holes)■ Printing (Heat transfer printing, silk screen printing, tempo printing) ■ Plastic Injection molding, sole base molding ■ Walker boot bonding ■ Metal Stamping ■ UV bonding, ultrasonic welding and high frequency welding ■ Others (Embroidery, fabric, vinyl, foam & film lamination, flame lamination)

骨科护具和医疗纺织品的生产我们的医疗车缝生产符合ISO13485要求, 在制造车缝医疗产品方面拥有超过15年的丰富经验。从简单的一次性使用产品到手术后的康复产品再到医生专用产品, 我们都有能力制造。我们的车缝制造能力包括:■ 纸样和放码设计控制(平板绘图机 &裁剪机) ■ 裁料(冲切、转台式斜切、刀切、剪裁、全自动裁剪)■ 车缝(包边、单针车、双针车、打枣、锁边、人字形针车、绗缝、钮门机) ■ 印刷(热转印、丝印、移印) ■ 塑胶注塑 ■ 鞋底注塑成型 ■ 步行鞋底贴合 ■ 金属冲压 ■ 紫外光贴合,超声焊和高周波焊 ■ 其他(绣花、织物、塑料、泡沫塑料和薄膜贴合、火烧贴合)

History 历史

1985 Vincent Raya established as contract manufacturer for industrial applications.1988 Main factory moved to Guang Dong Province, China.1997 Vincent Medical established, focused exclusively on medical disposable and reusable products.1999 Setup United States sales office in C.A.  2001 Install a world class EtO Sterilization System from US2003 ISO9002/ 13488/ 11135/ EN550/ cFDA/ CE certified.2004 ISO9001 & ISO 13485 certified. 2008 Set up own Microbiological Laboratory fulfill GMP standards2009 The 1st Hong Kong medical device company that certified for ISO14971 risk management standards, JGMP certified.2010 Install another EtO Sterilization System from France2010 Setup China Sales Office 2011 Setup a new 5 storeies of new production building with total 110,000 square feet area2012 Setup R&D center in Southern Medical University, China and Science Park in HongKong2013 The brand of inspired Orthopedics Healthcare launched

1985 永胜宏基集团成立, 成为工业应用产品的制造商

1988 工厂迁至中国广东1997 永胜医疗成立, 专业生产一次性和可重复性使用的 医疗产品1999 在美国加州设立销售办公室 2001 从美国引进一个世界级的环氧乙烷灭菌系统(ETO)2003 获得ISO9002/ 13488/ 11135/ EN550/ cFDA/ CE认证2004 获得ISO9001 & ISO 13485认证2008 建立达到GMP标准的微生物实验室2009 首家获得ISO14971风险管理认证的香港医疗设备制 造商2010 从法国引进另一个环氧乙烷灭菌系统(ETO)2010 中国销售办公室成立2011 5层高总面积达11万平尺的新办公和生产综合性大 楼建成2012 分别在中国南方医科大学和香港科技园设立研发中心

2013 推出自己品牌“英仕骨科康复”

Page 4: Facilities - Vincent Medical

Why partner with Vincent Medical? ■ Global Experience: Manufacturing for leading medical products companies in the United States, EU, Japan, S.E. Asia.■ Hong Kong Corporation/China Operation:Providing the optimum from“one-country,two systems”in communications, logistics, and established legal framework, management and controls.■ Qualified Manufacturing Environment:Class100,000 clean rooms, controlled environments and white room facilities.■ High quality:ISO9001, ISO13485 and CE certified. FDA and cFDA registered, compliance with GMP requirements.■ Reliable:Sophisticated project management and SAP system to ensure timely delivery and accurate budgeting.

为什么与永胜合作全球性的制造服务经验: 为美国、欧洲、日本、东南亚等行业领先的医疗设备公司代工的丰富经验。港资统筹/ 国内运营模式:在沟通、制造、物流方面上提供最合适的服务, 满足不同客户的要求。获得认证的制造环境: 100, 000级的无尘车间, 控制车间。高质量保证:通过ISO9001, ISO13485 and CE认证, 已注册FDA and cFDA, 符合GMP要求。可靠性:公司营运通过精细的项目管理和SAP系统, 确保准时出货, 达到客户要求。

Testing Equipments■ Universal Testing Machine(Tensile Testing Machine)■ Rubber Abrasion Tester■ Joint Aging Testing■ X3 Medical Seat Systerm■ Temperature & Humidity Tester■ Launder tester■ Metal Detector■ Daylight Tester■ Aging Oven■ Velcro Fatigue Tester

■ Sewing ( Binding, single straight stitching, double stitching, bar tacking, overlocking, zigzag stitching, quilting,button holes)■ Printing (Heat transfer printing, silk screen printing, tempo printing) ■ Plastic Injection molding, sole base molding ■ Walker boot bonding ■ Metal Stamping ■ UV bonding, ultrasonic welding and high frequency welding ■ Others (Embroidery, fabric, vinyl, foam & film lamination, flame lamination)

骨科护具和医疗纺织品的生产我们的医疗车缝生产符合ISO13485要求, 在制造车缝医疗产品方面拥有超过15年的丰富经验。从简单的一次性使用产品到手术后的康复产品再到医生专用产品, 我们都有能力制造。我们的车缝制造能力包括:■ 纸样和放码设计控制(平板绘图机 &裁剪机) ■ 裁料(冲切、转台式斜切、刀切、剪裁、全自动裁剪)■ 车缝(包边、单针车、双针车、打枣、锁边、人字形针车、绗缝、钮门机) ■ 印刷(热转印、丝印、移印) ■ 塑胶注塑 ■ 鞋底注塑成型 ■ 步行鞋底贴合 ■ 金属冲压 ■ 紫外光贴合,超声焊和高周波焊 ■ 其他(绣花、织物、塑料、泡沫塑料和薄膜贴合、火烧贴合)

History 历史

测试设备■ 万能测试仪(拉力测试仪)■ 耐磨测试仪■ 铰链老化测试仪■ X3 医疗座椅系统■ 温度湿度计■ 洗水测试机■ 金属探测器■ 颜色灯箱测试仪■ 老化试验机■ 粘扣带疲劳测试机

Page 5: Facilities - Vincent Medical

Cutting and Sewing Production products include:■ Orthopedic back braces■ Orthopedic knee braces■ Orthopedic elbow/ arm braces■ Orthopedic foot braces■ Rehabilitation and medical softgoods

Registrations and Certifications■ ISO9001■ ISO13485■ PRC cFDA■ U.S.QSR■ Japan Ministry of Health, Labour and Welfare■ Hong Kong Department of Health■ CE■ Customs- Trade Partnership Against Terrorism

Quality SystemsOur operation is ISO9001 and 13485 certified supported with compliance to the US FDA’s and GMP standard.Vincent Medical’s quality control and assurance procedures optimize consistent output to provide a safe, proven, repeatable product. Our comprehensive Quality Assurance program includes:■ Injection mold qualification & validation■ Incoming inspection and monitoring of all raw materials■ In-process monitoring and verification of manufacturing process■ 100% FQC and sampling OQA and testing■ Line patrolling inspection with sampling■ Statistical process control & C.I.P.■ Rigid compliance to documentation of customers■ Adhere to ISO9001 and ISO13485

车缝生产产品包括:■ 骨科后背支撑护具■ 骨科膝关节护具 ■ 骨科手肘/ 手臂护具■ 骨科足部护具■ 康复类和医用纺织品

注册和证书■ ISO9001■ ISO13485■ 中华人民共和国cFDA■ 美国QSR■ 日本卫生,劳动和福利部■ 香港卫生署■ CE■ C-TPAT

品质系统公司通过ISO9001 - 13485认证, 符合美国FDA和GMP标准。永胜医疗的质量控制系统保障了产品生产质量的一致性。

我们全面的质量保证计划包括:■ 注塑模具过程确认&验收■ 原材料的来料检查和监控(IQC)■ 生产过程制程监控和确认■ 100%成品检验和出货抽检检验和测试■ 线上抽检检验巡查■ 统计制程控制& C.I.P■ 严格遵守客户文件管理要求■ 遵循ISO9001 and ISO13485标准

Page 6: Facilities - Vincent Medical

Adjustable Knee Brace 膝盖支撑护具

Model no and Product Size Chart 产品型号和尺寸图

Model No 型号

L/R Size Product Description产品描述

Measurement尺寸

Colour颜色

50003771 - Universal 均码

Adjustable Knee Brace膝盖支撑护具

- Black 黑色

This adjustable knee brace allows the

user to adjust the length of hinge bar

for custom fitting. This product is ideal

for knee ligament damage, instable knee

and designed for postoperative fixation

and range of motion of knee.

Product Features

1. The hinge bars extendable from

16.5 – 27 (42cm – 68.5cm) which

fit for most patients.

2. Hinge range of motion adjustament:

Flexion( 0° to 120°) and extension

(0° to 90°).

3. Quick lock key offers ability to control

the hinge motion to 0°, 15° and 30°

directly.

4. The hinge bar locking system provides

security to users.

5. Light in weight and material

breathable.

6. Easy application with hook and

buckle closure.

7. Materials passed biocompatibility

and latex free.

8. Universal size, design fits either

left or right leg.

Indications

■ ACL, PCL, MCL, LCL repairs/injuries

■ Tibial plateau fractures

■ Osteochondral repairs

■ Meniscal repairs

■ Patella tendon repairs

■ Sprains/strains of the knee

■ HTOs (high Tibial osteotomy)

使用者可根据情况调节铰链式鋁臂的角度及

护膝套的长短。此产品用于受伤膝盖韧带的

保护、膝部不稳定的固定和手术后的固定及

控制膝部活动范围。

适用

■ 前交叉韧带、后交叉韧带、膝内侧

副韧带、外侧副韧带修复及受伤

■ 胫骨骨折

■ 膝骨软骨骨折修复

■ 半月板的修复

■ 膝盖骨、骨筋腱修复

■ 膝盖扭伤和拉伤

■ 高胫骨骨切开术

Adjustable Knee Brace膝盖支撑护具

Safety Lock伸缩安全扣

Hinge with quick lock feature快捷开关键

产品性能

1. 铰链式鋁臂的可调节伸缩范围:

16.5 -27 (42cm-68.5cm), 适用于大多数

病人。

2. 铰链式鋁臂可调节运动范围:

弯曲角度(Flexion)从0°到120°,

伸缩角度 (Extension) 从0°到90°。

3. 快捷开关鍵能直接調整角度到0°、15°和

30°, 易於使用。

4. 鋁臂上設有伸縮安全扣, 以鎖定鋁臂的伸

縮功能, 保障病人安全。

5. 產品重量轻,材质透气性好。

6. 么术貼綁帶與賿扣开合, 易于使用。

7. 材質通過生物兼容性測試及不含乳膠成份。

8. 均碼, 左/右腿適用。

Page 7: Facilities - Vincent Medical

Model no and Product Size Chart 产品型号和尺寸图

Model No 型号

L/R Size Product Description产品描述

Measurement尺寸

Colour颜色

50003786

50003786

L L

L

Universal 均码

Adjustable Elbow Brace, left 手肘护具,左

Black 黑色

The Inspired Adjustable Elbow Brace

Can be used for non-operative application,

collateral ligament strains and ruptures

and ulnar nerve transposition. It can be

used following early cast removal to

stabilize fractures and post-operative

immobilization.

Product Features

1. The Hinge bars extendable from

16 -20 (40.6-50.4cm) which fits for

most patients.

2. One size fits all. Adjustable bar for both

forearm and upper arm.

3. Protected range of motion from 0°

to 120° and/or lock the arm in any

position from 0° to 120° in 10°

increments.

4. Facilitates healing by maintaining

proper post-op positioning.

5. Comfortable with a removable hand

grip adjustable strap for the neck with

separate neck pad.

6. The handgrip ball can help to promote

blood circulation of arm.

Indications:

■ Stable fractures of the elbow, distal

humerus, proximal radius or ulna

■ Tendon and ligament injuries or

repairs

■ Chronic elbow injuries

■ Elbow hyperextension

■ Tennis elbow release

■ Collateral ligament reconstructions

■ Range of motion control post injury

■ Triceps tendon repair

手肘护具

可用于非手术骨折治療, 侧韧带拉伤和断

裂及尺骨神经移位等病症。亦可用于石膏

移除後固定骨折位和手术后肘部固定。

产品性能

1. 铰链式鋁臂可伸展範圍16 -12

(40.6-50.4cm), 适合大多数病人。

2. 均碼, 一个尺寸适合大部份人的手臂、

前臂和上臂的铰链式鋁臂可调节 。

3. 可鎖定手臂的活動范围从0°到120°裡,

每節調整單位為10°。

4. 手术后佩戴此护肘套以固定位置及活動

範圍, 便于治疗。

5. 手柄可隨需要而取下, 配以可调节的颈

带和颈带垫让病人配載感觉舒适。

6. 手抓球有助于促进手臂的血液循环。

适用

■ 固定手肘、远端臂骨、邻近的桡骨或

尺骨骨折

■ 筋腱和韧带受伤或修复

■ 慢性手肘受伤

■ 手肘过度伸展

■ 肘部发炎 (網球手)

■ 侧韧带复建

■ 受伤后控制手肘活动范围

■ 三头肌腱的修复

Adjustable Elbow Brace, right 手肘护具,左

50004119 R Universal均码

Black黑色

16”-20”

16”-20”

Adjustable Elbow Brace手肘护具

Handgrip ball 手抓球

Page 8: Facilities - Vincent Medical

Adjustable Elbow Brace (Black)手肘护具

Size: Universal (L/R)均码,分左右)

Adjustable Knee Brace (Black)膝盖支撑护具

Size: Universal 均码

Hinged Knee Brace (Black) 护膝支具

Size: S/ M/ L

Functional Arm Brace 手臂骨折护具

Size: S/ M/ L

Functional Upper Arm Brace 上臂骨折护具

Size: S/ M/ L

Functional Forearm Brace 前臂骨折护具

Size: S/ M/ L

Page 9: Facilities - Vincent Medical

Arm Sling(Black)手臂吊带Size: XS/S/M/L/XL

Wrist Brace (Black) 腕关节支具Size:Universal (L/R) 均码(分左右)

Anti-fungal Hygienic Sock (Black)微胶囊香港脚袜Size:Universal 均码

Airpad Ankle Brace 充气式踝关节 Size:Universal 均码

Limb Holder (Grey) 四肢固定带 Size:Universal 均码

Heel Pillow 足部垫枕 Size: Small/Regular 小码/标准码

Thumb & Wrist Brace (Black) 拇指托具 Size:Universal (L/R) 均码(分左右)

Ankle Brace with Strap(Black)踝关节支具Size: XXS/XS/S/M/L/XL

Page 10: Facilities - Vincent Medical

Vincent Rehab Devices Co.,Ltd