Medical Device Marketing Authorization
Product-specific SFDA authorization for the STEMA Micro System plates, mesh and screws listed in the annex.
Official files, clearly organized
The Aonkor
Downloads Center.
Access the exact uploaded catalog, selected regulatory records, manufacturer quality certificates and available product literature.
CATALOG · CERTIFICATES · IFU · LITERATURE
AONKOR / DOWNLOADSOFFICIAL AONKOR CATALOG
ORIGINAL PDF · UNMODIFIED
ORIGINAL PDF · UNMODIFIEDPrimary publication
Aonkor International
Product Catalog
The complete official product catalog is published here as the exact uploaded PDF. It has not been recreated, edited or summarized.
Regulatory certificates
Selected records
for institutional review.
Seven current, high-value records were selected from the full uploaded package.
Authorized Representative License
SFDA license naming Aonkor International as the authorized representative for STEMA Medizintechnik GmbH for non-active implantable devices.
Medical Device Establishment License
SFDA establishment license authorizing Aonkor International to operate as a medical device importer and distributor.
Medical Device Warehouse License
SFDA warehouse license for Aonkor International covering medical devices, IVD products and controlled-temperature products at the licensed Riyadh facility.
EN ISO 13485 Quality Management Certificate
Manufacturer quality-management certification covering development, manufacturing and distribution within the scope stated on the certificate.
EU MDR Quality Management System Certificate
STEMA quality-system certification under Regulation (EU) 2017/745 Annex IX for the device scope stated in the certificate.
STEMA–Aonkor Authorized Representative Agreement
Signed manufacturer agreement appointing Aonkor International for authorized-representative responsibilities in Saudi Arabia for the covered device category.
Product literature & IFU
Available source
documents.
These files are exact copies from the uploaded manufacturer package. Approved labeling and current market status must be confirmed for the specific product.
Titanium Meshes & Plating Flyer
STEMA product flyer covering selected titanium meshes, mini plates and screws.
Bone Screws & Bone Plates IFU
Manufacturer instructions for use covering bone screws, bone plates and associated accessories.
Documents by request
The right file for
the right audience.
Some materials should be matched to the product, procedure and procurement context rather than posted without qualification.
Company Profile
Request the current institutional company profile for procurement or partnership review.
Request this resource↗Additional Brochures
Ask for product literature matched to the relevant surgical system.
Request this resource↗Additional IFU
Request the current instructions for use for a specific product reference.
Request this resource↗Clinical Documents
Request available clinical or technical documentation relevant to the intended system.
Request this resource↗Tender Document Pack
Share the tender reference and deadline for a focused documentation response.
Request this resource↗Future Publications
Contact Aonkor for publication or document-availability enquiries.
Request this resource↗Move forward with Aonkor
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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.