German Manufacturing Standards
Manufacturer origin, facility and certification scope are verified against current uploaded records.
Quality without overstatement
A controlled path
from manufacturer to market.
Aonkor connects current manufacturer quality evidence with licensed Saudi operating activities and product-specific regulatory documentation.
QUALITY · TRACEABILITY · SAUDI READINESS
AONKOR / QUALITY & COMPLIANCEQuality & compliance framework
Six controls.
One evidence standard.
Every claim is tied to the applicable company license, manufacturer certificate or product authorization—never assumed across the full portfolio.
Premium Quality Assurance
The current EN ISO 13485 certificate documents STEMA’s quality-management scope for the listed activities and products.
Product Traceability
Product, lot, material and documentation records are coordinated through the applicable manufacturer and supply pathway.
International Manufacturing Excellence
A current EU MDR quality-system certificate documents notified-body oversight for its stated device scope.
Saudi Market Readiness
Aonkor’s current establishment, authorized-representative and warehouse licenses support the licensed activities stated by SFDA.
Regulatory Compliance
The current MDMA annex specifically identifies STEMA Micro System plates, mesh and screws authorized for the Saudi market.
Documented quality chain
From German quality systems
to Saudi market readiness.
Responsibility remains distinct at every stage.
Manufacturer quality system
STEMA’s current EN ISO 13485 certificate.
EU regulatory quality system
Current notified-body certificate under EU MDR Annex IX.
Manufacturer appointment
Signed and apostilled authorization agreement.
Saudi establishment activities
Current SFDA importer/distributor and warehouse licenses.
Product marketing authorization
MDMA annex for listed Micro System plates, mesh and screws.
Hospital documentation
Current product files supplied according to system and request.
Trust & compliance
Confidence is documented.
Every statement below links to a selected uploaded record. Product scope remains limited to the devices and activities stated in each document.
SFDAView official record ↗ISOView official record ↗MDRView official record ↗ARView official record ↗
Medical Device Marketing Authorization
STEMA Micro System plates, mesh and screws are listed in the current authorization annex.
EN ISO 13485
Current manufacturer quality-management certification, registration D1093700046.
EU MDR quality system
Current notified-body quality-system certificate, registration D1093700045.
Manufacturer authorization
Signed, apostilled STEMA–Aonkor authorized-representative agreement.
Procurement-ready support
Need a current document pack
for a specific system?
Tell us the product family, hospital, procurement stage and deadline. We will route the request to the relevant Aonkor specialist.
Move forward with Aonkor
Ready to Discuss Your Next Surgical Project?
Whether you are equipping a hospital, supporting a surgical department, or looking for premium German medical technologies, Aonkor International is ready to support your clinical and procurement needs across Saudi Arabia.