Certifications & compliance
Everything below is auditable, verifiable and available as PDF for your tender or vendor-qualification file. Request certificate copies at info@idrak-pharma.com.
ISO 13485:2016
Medical devices — quality management systems: manufacture and export of non-active surgical & dental instruments
- Amtivo Group Limited (UK)
- Certificate no. 622547
- Issued Dec 21, 2022
ISO 9001:2015
Quality management system: manufacturer and exporter of surgical and dental instruments and PPE
- GSCI Services GmbH (Germany) — UAF accredited
- Certificate no. GSCI-PAK/QMS/2025/010
- Issued Oct 9, 2025
CE Mark — Class I Medical Devices
Re-useable surgical and dental instruments — Class I medical devices
- DCS Certification (EU Directive 93/42/EEC as amended 2007/47/EC)
- Certificate no. DCS/9461884
- Issued Jan 18, 2025
US FDA Establishment Registration
Registered manufacturer of surgical instruments for the United States market
- U.S. Food & Drug Administration
- Certificate no. FDA Listed
SFDA Registration
Registered for the Kingdom of Saudi Arabia market
- Saudi Food & Drug Authority
- Certificate no. SFDA Registered
Regulatory registrations by market
Instruments are manufactured as Class I re-useable medical devices under EU Directive 93/42/EEC (as amended by 2007/47/EC), with full technical files and lot-level traceability. Certificates are issued in the name of our manufacturer, INSTRUMED (Pvt) Ltd., 65-B Small Industries Estate, Sialkot — crafting surgical instruments since 1974 and a major supplier for NUPCO tenders in Saudi Arabia. Certificates are subject to annual surveillance audits — always verify current status with the issuing body before tender submission.