Quality & Certifications

Certifications & Quality Assurance

Our instruments are CE & ISO 13485-certified and manufactured under strict quality management. Each product is registered with the relevant regulatory authorities for full compliance.

CE

CE & ISO 13485 Certified

All instruments meet European CE certification requirements and ISO 13485 international quality management standards.

  • CE marking under EU MDR
  • ISO 13485 quality management system
  • Audited manufacturing process
  • Certificates available on request
SS

Medical-Grade Stainless Steel

Premium medical stainless steel: sharp, corrosion-resistant, sterilizable.

  • High-grade 420/440 medical stainless steel
  • Precision forged, not cast
  • Autoclave sterilizable
  • Corrosion-resistant surface finish
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Full Traceability

Every product is registered with the relevant regulatory authorities for compliance and traceability.

Every instrument is registered with the relevant regulatory authorities. Specific registration numbers are confirmed in writing (quotation or sales contract) for your order.

QC

Rigorous QC Process

In-house quality control at every production stage.

  1. Raw material inspection
  2. In-process dimensional check
  3. Surface finish & hardness test
  4. Function & fit test
  5. Final packaging inspection

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