FUMO Achieves ISO 13485 Certification, Strengthening Its Commitment to Quality

author: FUMO

2025-01-22

Introduction: A Milestone in Excellence

FUMO Paper Products Co., Ltd. is proud to announce its successful certification under ISO 13485:2016, an internationally recognized standard for quality management systems in the medical device industry. This certification demonstrates FUMO’s unwavering dedication to producing high-quality disposable medical and healthcare products. As a trusted supplier for over 25 years, this achievement further solidifies FUMO’s position as a leader in the global market.

A Legacy of Innovation and Trust

Founded in 1999 by mechanical engineer Mr. Feng Yunsheng and his brother, FUMO has become synonymous with quality and reliability in disposable medical supplies. With proprietary technologies such as the FUMO PE laminating process and a robust OEM portfolio, FUMO’s products are now exported to over 60 countries. Trusted by top brands, including Medline, Ansell, Alimed, and Dukal, FUMO consistently strives to help clients grow their business, enabling them to sell three times more.

State-of-the-Art Facilities and Rigorous Quality Control

FUMO operates a 3,000 m² production workshop equipped with 23 advanced production lines, including 16 rolling and cutting machines and a dust-free workshop. With a production capacity of one 40HQ container every seven days, FUMO meets the high-volume demands of its clients efficiently. Rigorous quality assurance measures, from incoming material inspections to final product testing, ensure that every item meets international standards.

Comprehensive Product Range

As highlighted in the certification, FUMO’s extensive product portfolio includes disposable medical and healthcare items such as:

Exam paper rolls
Couch rolls
Examination table paper rolls
Chiropractic face paper rolls
Hospital bed sheets
Massage table covers
Disposable pillowcases
Exam gowns and capes
Tissue+Poly+Tissue medical gowns
FUMO’s products cater to a wide range of needs in the medical, spa, and wellness industries, ensuring maximum comfort and hygiene for end-users.

New Competitive Advantages:

This milestone aligns with FUMO’s recent initiatives to offer unparalleled value to clients, including:

Exclusive Supplier for a Top 3 Amazon Table Paper Brand: Partnering with a leading seller to deliver high-quality table paper rolls.
24/7 Video Inspection and Factory Tour Services: Allowing clients to remotely verify product quality and explore factory operations via video or live streaming.
Daily Output of Over 10,000 Bed Rolls: Ensuring the capacity to meet large-scale demands.
Proven OEM Expertise: Helping brand owners increase sales by three times with tailored manufacturing solutions.

Commitment to a Brighter Future

FUMO's ISO 13485 certification is a testament to its dedication to excellence and continuous improvement. With a focus on quality, innovation, and customer satisfaction, FUMO is poised to remain a trusted partner in the global medical and healthcare industry.

Partner with FUMO Today

If you are looking for top-quality disposable medical and healthcare products backed by ISO 13485 certification, FUMO is your ideal partner. Visit our website to explore our full range of products and services. Schedule a 24/7 video inspection or factory tour to witness our commitment to quality firsthand. Join the ranks of global brands that trust FUMO to take their business to new heights.