In the medical and healthcare industry, FDA registration is one of the most recognized and trusted compliance standards worldwide.
As a professional manufacturer of Hot Cold Packs and Ice Packs, Yishun is proud to be a Class I FDA Registered Medical Device Manufacturer.
This certification ensures that our products meet the stringent requirements of the U.S. Food and Drug Administration in terms of design, material selection, production, and quality management. For our customers, this is not just a certification – it is a guarantee of safety, compliance, and trust.
👉 You can directly verify our FDA registration through the official FDA database:
Click here to search on FDA Establishment Registration & Device Listing
Search us: Jiangsu Yishun Medical Equipment Co., Ltd
Simply enter our company name to confirm our registration – transparent, reliable, and trustworthy.
Beyond FDA – Our Global Certifications
In addition to FDA registration, Yishun also holds multiple internationally recognized certifications, including:
ISO 13485 Certification – Quality Management System specifically for medical devices
MHRA Registration (UK) – Compliance with the UK Medicines and Healthcare products Regulatory Agency
MDD Certification (EU) – Compliance with the European Medical Device Directive, enabling access to EU markets
These certifications provide our partners with the confidence to expand into global markets with full compliance.
How Our Certifications Benefit Our Customers
Trust & Compliance
FDA registration proves that our products meet international medical device standards, ensuring confidence for distributors, healthcare providers, and end users.Market Access
With FDA, ISO, MHRA, and MDD certifications, our customers can easily enter the U.S., UK, and EU markets with compliant products.Safety First
All products are made from FDA-approved, non-toxic materials, suitable for hospitals, pharmacies, and home care.Customization Support
We provide OEM/ODM services, allowing customers to customize product design, packaging, and formulations to build a stronger market advantage.
Yishun – Compliance You Can Trust
At Yishun, FDA registration is more than a credential – it is our promise to deliver safe, compliant, and high-quality medical products to customers worldwide. Combined with ISO, MHRA, and MDD certifications, we provide the assurance needed for long-term, global partnerships.
Choosing Yishun means choosing safety, compliance, and global trust.