Do Your Products Comply With RoHS and REACH?
Surgical Star is a B2B surgical-instrument manufacturer in Sialkot, Pakistan, forging German-grade stainless steel instruments under private label for distributors and brands worldwide — ISO 13485, CE-marked (EU MDR 2017/745) and FDA-registered. Below is the fuller context behind the answer above, and what it means for your order.
Every instrument Surgical Star manufactures is produced within a documented ISO 13485 quality management system — the medical-device standard your own regulatory file depends on. CE marking is offered under EU MDR 2017/745 for the European market, and our facility holds US FDA establishment registration.
On request we provide certificates of conformity, ISO certificates and ASTM F899 material certificates for the specific steel used in your order. For US buyers we also support 510(k) documentation where your product class requires it, and for Canada, Australia and the Gulf we prepare paperwork matched to Health Canada MDEL, TGA and local registration.
Because we control forging through finishing in-house, the traceability behind those certificates is genuine — hardness testing, passivation records and inspection all happen under one roof in Sialkot.
What This Means for Your Order
In practice, sourcing from Surgical Star means dealing directly with the factory that forges, finishes and marks your instruments — not a trading house reselling someone else’s work. You send an instrument list or reference sample, approve a branded pre-production sample, and receive bulk with the certificates and documentation your market requires. MOQs stay low and new-brand-friendly, pricing is volume-tiered, and delivery is worldwide DDP. If you are comparing manufacturers, ask each for their ISO 13485 certificate, steel grade and sample policy — it is the fastest way to tell a real factory from a middleman.
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Frequently Asked Questions
Do Your Products Comply With RoHS and REACH?
Our stainless-steel instruments contain no restricted RoHS substances and are supported by REACH-aligned material declarations on request. As solid surgical stainless, they carry none of the hazardous substances those regulations target.
Can I order a sample before bulk?
Yes. Surgical Star produces a pre-production sample with your laser-marked branding before any bulk run, so you approve finish, dimensions and marking first. You never order blind.
Do you ship worldwide?
Surgical Star ships worldwide on DDP, FOB or CIF terms — including the USA, EU, UK, Canada, Australia and the Gulf — and handles customs documentation and HS codes so instruments arrive at your door.
Do you manufacture under our own brand?
Yes — Surgical Star is a full OEM and private-label manufacturer. We laser-mark your logo and catalog numbers, pack in your branded boxes, and manufacture from your drawings, samples or tech packs, with a sample approved before bulk.
Talk to the factory directly — certified, private-label instruments with low MOQ and sample before bulk.
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