Quality & Certification

ISO 13485 & CE Certified Surgical and Dental Instruments

Precision Crafted. Surgeon Trusted. Certified quality, CE marked instruments and surgical grade stainless steel for hospitals, clinics and distributors worldwide.

  • ISO 13485 Certified
  • CE Marked
  • FDA CGMP Guidelines
  • Surgical Grade Stainless Steel
ISO 13485

Certified quality system for medical device manufacturing.

CE Mark

Meets EU safety requirements for our instruments.

FDA CGMP

Production follows US FDA CGMP guidelines.

Autoclave Safe

Surgical grade stainless steel, safe for repeated sterilization.

Quality you can verify

Certified to the standards surgeons and distributors expect

Hamsan Surgical is a certified and registered manufacturer of surgical and dental instruments.

We are an approved member of the Surgical Instruments Manufacturers Association (SIMAP) and hold a valid Free Sale Certificate from the Chamber of Commerce & Industry. This confirms our instruments are legally manufactured and sold in both local and international markets.

Our quality system is certified to ISO 13485, the global standard for medical device manufacturing. Our instruments carry the CE mark, meeting EU safety requirements, and our production follows FDA CGMP guidelines in the US.

All instruments are made from surgical grade stainless steel and are safe for repeated autoclave sterilization.

These certifications show our commitment to quality, safety, and reliability for hospitals, clinics, and distributors around the world.

Credentials at a glance

  • Approved member of the Surgical Instruments Manufacturers Association (SIMAP)
  • Valid Free Sale Certificate from the Chamber of Commerce & Industry
  • Authorized manufacturer and exporter of surgical and dental instruments
  • Legally manufactured and approved for distribution worldwide
  • Manufacturing practices aligned with international ISO and CE quality standards
Our certificates

Officially Certified. Legally Exported. Globally Trusted.

Tap or click any certificate to view it at full size.

ISO 13485 Certificate

Quality management system for medical device manufacturing.

CE Certificate

Conformity with EU safety requirements.

SIMAP Membership

Approved member of the Surgical Instruments Manufacturers Association.

Free Sale Certificate

Confirms our instruments are legally manufactured and sold in local and international markets.

25+

Years of precision manufacturing

2007

Exporting globally since

Worldwide

Export markets across every major region

FAQ

Frequently asked questions about our quality standards

Yes. Our quality system is certified to ISO 13485, the global standard for medical device manufacturing.

Yes. Our instruments carry the CE mark, meeting EU safety requirements.

Yes. Our production follows FDA CGMP guidelines in the US.

Yes. All instruments are made from surgical grade stainless steel and are safe for repeated autoclave sterilization.

Yes. We have exported globally since 2007 and hold a valid Free Sale Certificate confirming our instruments are legally manufactured and sold in local and international markets.

Sourcing for a clinic, hospital or distribution business?

Speak with the Hamsan Surgical export team about your requirements.

Contact Our Export Team