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Worldwide shipping with door-to-door delivery全球发货,门到门配送
MediCore Health logoMediCore Health迈迪康医疗Medical Devices & Health医疗器械与健康

A factory you can visit, a partner you can trust可实地验厂的工厂,值得信赖的伙伴

From raw material to door delivery, we control every step.从原材料到门到门交付,全流程自主把控。

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Export countries出口国家
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Devices shipped累计交付设备
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On-time delivery准时交付率
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Export experience出口经验
Our Story品牌故事

A factory you can visit, a partner you can trust可实地验厂的工厂,值得信赖的伙伴

MediCore Health started in 2011 as a small Ningbo workshop assembling pulse oximeters and digital thermometers for local distributors. Our first export order, 5,000 thermometers to Vietnam, shipped the following year in a single air pallet.迈迪康医疗成立于 2011 年,最初是宁波一家小型车间,为本地经销商组装血氧仪与电子体温计。第二年,我们向越南发出首个出口订单——5,000 支体温计,仅用一个空运板。

Today we operate a 28,000 m2 facility with 260 employees, including a Class 100,000 clean assembly room and a 34-person engineering and regulatory team handling design controls and registration files in house.如今公司厂区面积 28,000 平方米,员工 260 人,拥有十万级洁净装配车间,以及 34 人的工程与法规团队,独立完成设计控制与注册文件。

We ship to 46 countries and support hospitals, distributors and home-care providers with bilingual specialists, remote clinical training and an eight-year spare parts commitment.产品出口 46 个国家,通过双语专员、远程临床培训与 8 年备件承诺,服务医院、经销商与居家护理机构。

28,000 m2 GMP manufacturing base28,000 平方米 GMP 生产基地
260 employees, 34 engineers and regulators260 名员工,34 名工程与法规人员
ISO 13485 / CE MDR / FDA 510(k)ISO 13485 / CE MDR / FDA 510(k)
8-year spare parts guarantee8 年备件保障
Founded成立时间
2011
Employees员工人数
260+
Factory Area厂房面积
28,000 m2

Milestones发展历程

More than a decade of manufacturing and export experience.十余年制造与出口经验沉淀。

2011
Company founded公司成立
A small Ningbo workshop began assembling oximeters and thermometers.宁波小型车间开始组装血氧仪与体温计。
2014
ISO 13485 certification通过 ISO 13485 认证
Quality system certified and the first hospital tender won.质量体系通过认证,中标首个医院招标项目。
2017
CE marking for core range核心产品取得 CE 认证
Technical files completed for monitors, nebulizers and diagnostics.监护、雾化与诊断类产品完成技术文件。
2020
New 28,000 m2 plant28,000 平方米新厂投产
Clean assembly room and automated test line brought into service.洁净装配车间与自动化测试线投入使用。
2024
FDA 510(k) and home-care lineFDA 510(k) 与家庭护理产线
Oximeter and blood pressure clearances granted; home-care division launched.血氧仪与血压计获 FDA 许可,成立家庭护理事业部。

Quality Control品质管控

Every shipment passes a documented multi-stage inspection.每一批货都经过完整的多道质检流程。

01
Incoming component inspection来料检验
Sensors, batteries and PCBs are batch-tested with calibrated instruments on arrival.传感器、电池与电路板到厂后使用校准仪器进行批次检测。
02
Cleanroom assembly洁净车间装配
Patient-contact products are assembled in a Class 100,000 controlled environment.与患者接触的产品在十万级受控环境中装配。
03
100 percent functional test100% 功能测试
Every unit runs a full parameter and safety test before packing.每台设备在包装前完成全参数与安全测试。
04
Traceability and final release追溯与放行
Batch records link each serial number to components, test data and operator.批记录将每个序列号与元器件、测试数据及操作员关联。

Certifications资质认证

Certified for the markets we serve.满足目标市场准入与认证要求。

CE MDR
EU Medical Device Regulation 2017/745欧盟医疗器械法规 2017/745
FDA 510(k)
US premarket notification clearance美国上市前通知许可
ISO 13485
Medical device quality management医疗器械质量管理体系
ISO 9001
Quality management system质量管理体系
NMPA
China medical device registration中国医疗器械注册
MDSAP
Single audit program records医疗器械单一审核程序记录
Global Markets全球市场

Global Markets全球市场

Our products are exported to more than 60 countries across five continents.产品出口至五大洲 60 多个国家和地区。

United States
Germany
Brazil
Mexico
Vietnam
India
UAE
Saudi Arabia
Turkey
Poland
Australia
Thailand
Global footprint

Meet the Team核心团队

Dedicated export, engineering and QC specialists.专业的出口、工程与品控团队。

Li Wenhao
Li Wenhao李文浩
General Manager总经理

18 years in medical device manufacturing and export operations.18 年医疗器械制造与出口运营经验。

Grace Chen
Grace Chen陈嘉怡
Export Director外贸总监

Leads a bilingual team serving hospitals and distributors in 46 countries.带领双语团队服务 46 个国家的医院与经销商。

Wu Jian
Wu Jian吴健
Chief Engineer总工程师

Responsible for design controls, firmware and CE technical files.负责设计控制、固件与 CE 技术文件。

Rachel Sun
Rachel Sun孙瑞雪
Regulatory Affairs Manager法规事务经理

Manages ISO 13485 audits, FDA 510(k) submissions and MDSAP records.负责 ISO 13485 审核、FDA 510(k) 申报与 MDSAP 记录。

Frequently Asked Questions常见问题

Frequently Asked Questions常见问题

Everything you need to know before placing an export order.下单前您可能想了解的一切。

Contact Us联系我们

Send Inquiry发送询盘

Submit your requirements and our export team replies within 2 hours.提交需求,外贸团队将在 2 小时内回复。

Contact Us联系我们

Still have questions?还有其他问题?

Our export specialists reply within 2 working hours.外贸专员将在 2 个工作小时内回复。

Fast Global Shipping全球快速配送
Door-to-door delivery in 3-15 days3-15 天门到门配送
Trade Assurance贸易保障
Payment protected until delivery货款保障至货物签收
Easy Returns无忧退换
30-day quality guarantee30 天质量保证
24/7 Export Support7×24 外贸支持
Dedicated account manager一对一客户经理