Question 1

What steel grades do you use for surgical instruments?

Accepted Answer

Reusable cutting and clamping instruments are forged from German-grade AISI 410, 420 and 440 martensitic stainless steel, while holloware, trays and sterilising drums use AISI 304 and 316 austenitic stainless steel. Tungsten carbide inserts are brazed into needle holders and scissors on request.

Question 2

What is the minimum order quantity for OEM private label instruments?

Accepted Answer

Private label and OEM branding starts at 300 units per pattern. Laser marking, custom logos, ring colour coding, printed cartons and your own catalogue numbers are all supported.

Question 3

Are your instruments CE marked and ISO 13485 certified?

Accepted Answer

Yes. Our quality management system is certified to ISO 13485:2016 and ISO 9001:2015, and our reusable instruments are CE marked as Class I devices under EU MDR 2017/745 with EUDAMED registration. Our facility also holds an FDA establishment registration (3019842214).

Question 4

How long does production and delivery take?

Accepted Answer

Stock patterns ship in 7-10 working days. Custom and OEM orders are produced and delivered within 10-20 working days by DHL, FedEx, air freight or sea freight, with full export documentation.

Question 5

Do you provide samples before a bulk order?

Accepted Answer

Yes. Distributors and hospital buyers can request sample instruments for inspection, sterilisation validation and surgeon evaluation before confirming a production order.

Blog

2026 Top Dental Extracting Forceps Types for Global Buyers