Quality, Steel & Finishing

Quality, steel & finishing — German-grade stainless steel (AISI 420 / 316L), passivated, mirror or satin finish, ASTM F899, ISO 13485 QC.

ISO 13485 CE / EU MDR FDA Registered German-grade steel

Quality starts with steel. Surgical Star forges instruments from German-grade AISI 420 martensitic stainless and, where corrosion resistance demands it, 316L — passivated and finished to a mirror or satin surface, ISO 13485, CE-marked (EU MDR 2017/745) and FDA-registered.

Steel Grades

AISI 420 martensitic stainless is our default for cutting and grasping instruments, chosen for edge retention. 316L austenitic stainless is used for retractors, holloware and instruments needing maximum corrosion resistance. All steel meets ASTM F899.

Finishing

After forging and heat treatment, every instrument is passivated to build its protective chromium-oxide layer, then finished to your specified mirror or satin surface. The result is autoclavable and corrosion-resistant.

Quality Control

Hardness testing, dimensional checks and visual inspection happen in-house under our ISO 13485 system. Third-party inspection is welcome before dispatch, and a pre-production sample is approved before every bulk run.

Frequently Asked Questions

What certifications do you hold?

ISO 13485 quality management, CE marking under EU MDR 2017/745, and US FDA establishment registration, with certificates supplied on request.

What is your MOQ?

Low and new-brand-friendly, varying by instrument and finish — send your list for a realistic minimum and volume-tiered pricing.

Do you ship worldwide?

Yes — DDP, FOB or CIF to the USA, EU, UK, Canada, Australia and the Gulf, with documentation handled.

See Also

Source instruments built on real steel
German-grade stainless steel, mirror/satin finish, sample before bulk.
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ISO 13485, CE-marked and FDA-registered instruments under your own brand — low MOQ, a sample before every bulk run, and worldwide DDP shipping. Tell us what you need.

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