OEM & Private-Label Manufacturing

OEM & private-label surgical instrument manufacturing — your logo, German-grade stainless steel, ISO 13485, CE-marked (EU MDR 2017/745) and FDA-registered…

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

Building your own instrument brand? Surgical Star is a full OEM and private-label manufacturer — your logo, your catalog numbers, your packaging, forged from German-grade stainless steel and ISO 13485, CE-marked (EU MDR 2017/745) and FDA-registered.

What Private Label Includes

  • Laser logo marking on every instrument
  • Your catalog / item numbers engraved
  • Branded boxes, sleeves and inserts
  • Manufacturing from your drawings, samples or tech pack (OEM / ODM)
  • Certificates of conformity and material certificates under your order

How It Works

  1. Send your instrument list and branding.
  2. Approve a pre-production sample with your logo.
  3. We run bulk with in-house QC — third-party inspection welcome.
  4. We pack in your boxes and ship DDP.
Low MOQ: new-brand-friendly minimums and volume-tiered pricing mean you can launch without a large first order.

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

Launch your private-label line
Direct factory pricing, laser branding and sample before bulk.
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Source Your Instruments Direct From the Factory

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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