About

About Top-Bound

Established in 1991, Top-Bound Enterprise Co., Ltd. has more than three decades of experience in manufacturing, product development, and custom solutions for customers across a range of industries.

Company

Company Profile

Founded in 1991, Top-Bound Enterprise Co., Ltd. specializes in Zebra Connector production, heating technology, and ODM / OEM services. The company is licensed to manufacture and sell medical devices.

We develop and manufacture far-infrared silicone rubber heating pads, heating modules, heating products, and medical devices. Materials, dimensions, specifications, and process integration can be tailored to each project. Backed by more than three decades of industry experience, our ISO 9001, ISO 14001, ISO 13485, and QMS-compliant systems support reliable products and manufacturing solutions for customers worldwide.

Quality & Certifications View Patent Information

Overview

Company Overview

1991

Established

Founded in 1991 with a long-term focus on manufacturing and custom production services.

30+

Years of Experience

More than three decades of manufacturing, technical, and industry experience.

ODM / OEM

Development & Custom Manufacturing

Product development, design, manufacturing, and custom production services.

ISO / QMS

Quality Management Systems

Quality, environmental, and medical device management systems.

Quality

Quality & Certifications

Top-Bound maintains quality management systems and emphasizes regulatory compliance, product testing, and verification to support reliable manufacturing and customer service.

Certified

QMS

Medical Device Quality Management System (QMS) manufacturing permit.

Permit No.: QMS2039

Valid Until: Mar 21, 2028

View Document
Certified

ISO 9001:2015

Quality Management System

Valid Until: Jan 28, 2029

Certification Scope: Manufacturing of silicone rubber connectors and powered heating pads.

View Certificate
Certified

ISO 14001:2015

Environmental Management System

Valid Until: Mar 8, 2029

Certification Scope: Manufacturing of silicone rubber connectors and powered heating pads.

View Certificate
Certified

ISO 13485:2016

Medical Device Quality Management System

Valid Until: May 2, 2028

Certification Scope: Design, manufacture, sale, and distribution of powered heating pads.

IMQ / CISQ certified · IQNet recognized

View Certificate

Product Compliance

Compliant

Taiwan Food and Drug Administration (TFDA)

Compliance with applicable TFDA requirements.

Compliant

RoHS

Products meet RoHS hazardous substance restrictions.

Compliant

REACH

Products comply with applicable REACH requirements.

Medical Device Licenses

Medical device manufacturing license
Licensed

Medical Device Manufacturing License

License covering medical device manufacturing operations.

View Document
Medical device sales license
Licensed

Medical Device Sales License

License covering medical device sales operations.

View Document

Detailed documents are available upon request.

Patents

Taiwan

  • M263923
  • M279351
  • M280067
  • M287025
  • M293683
  • M328734
  • M372704
  • M388938
  • M414045
  • M433758
  • M456832
  • M550954

China

  • ZL 2004 2 0043016.2
  • ZL 2005 2 0104902.6
  • ZL 2005 2 0066472.3
  • ZL 2005 2 0114806.X
  • ZL 2005 2 0114805.5
  • ZL 2007 2 0142723.0
  • ZL 2010 2 0224117.5
  • ZL 201120106942.X
  • 201120224253.9
  • ZL201220114371.9
  • ZL 2020 21561019.0

Japan

  • 3119584

Germany

  • 20 2006 013 634.7

Need more information about our products, certifications, or custom solutions?

Contact Top-Bound for product details, certification documents, or a custom solution tailored to your project requirements.

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